PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.

开始日期2024-12-31

申办/合作机构

Puma Biotechnology, Inc.

NCT06095505 / Recruiting临床2期

A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.

开始日期2024-02-08

申办/合作机构

Puma Biotechnology, Inc.

NCT04555837 / Active, not recruiting临床1/2期IIT

A Phase I-II, Open Label Study Evaluating the Safety and Efficacy of Alisertib and Pembrolizumab in Patients With Rb-Deficient Head and Neck Squamous Cell Carcinomas

This phase I/II trial investigates the best dose and effect of alisertib in combination with pembrolizumab in treating patients with Rb-deficient head and neck squamous cell cancer. Alisertib may help block the growth of cancer.. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving alisertib in combination with pembrolizumab may help control Rb-deficient head and neck squamous cell cancer. HPV positive head and neck cancers are Rb-deficient.

开始日期2020-09-15

申办/合作机构

The University of Texas MD Anderson Cancer Center

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100 项与 Alisertib 相关的专利（医药）

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311

项与 Alisertib 相关的文献（医药）

2024-02-01·Hepatology (Baltimore, Md.)

Multiomics identifies metabolic subtypes based on fatty acid degradation allocating personalized treatment in hepatocellular carcinoma

Article

作者: Wang, Ye ; Yu, Decai ; Liu, Qi ; Li, Huan ; Li, Binghua ; Xu, Yanchao ; Mehal, Wajahat Z ; Qian, Liyuan ; Zhou, Huajun ; Lu, Jiaming ; Cao, Yajuan ; Zhang, Yuchen ; Xu, Zhu ; Su, Ke ; Xie, Yuanyuan ; Guo, Sheng ; Li, Yunzheng ; Lu, Yijun ; Zhang, Laizhu ; Hu, Yue ; Peng, Jin ; Cheng, Chunxiao

Background and Aims::

Molecular classification is a promising tool for prognosis prediction and optimizing precision therapy for HCC. Here, we aimed to develop a molecular classification of HCC based on the fatty acid degradation (FAD) pathway, fully characterize it, and evaluate its ability in guiding personalized therapy.

Approach and Results::

We performed RNA sequencing (RNA-seq), PCR-array, lipidomics, metabolomics, and proteomics analysis of 41 patients with HCC, in which 17 patients received anti-programmed cell death-1 (PD-1) therapy. Single-cell RNA sequencing (scRNA-seq) was performed to explore the tumor microenvironment. Nearly, 60 publicly available multiomics data sets were analyzed. The associations between FAD subtypes and response to sorafenib, transarterial chemoembolization (TACE), immune checkpoint inhibitor (ICI) were assessed in patient cohorts, patient-derived xenograft (PDX), and spontaneous mouse model ls. A novel molecular classification named F subtype (F1, F2, and F3) was identified based on the FAD pathway, distinguished by clinical, mutational, epigenetic, metabolic, and immunological characteristics. F1 subtypes exhibited high infiltration with immunosuppressive microenvironment. Subtype-specific therapeutic strategies were identified, in which F1 subtypes with the lowest FAD activities represent responders to compounds YM-155 and Alisertib, sorafenib, anti-PD1, anti-PD-L1, and atezolizumab plus bevacizumab (T + A) treatment, while F3 subtypes with the highest FAD activities are responders to TACE. F2 subtypes, the intermediate status between F1 and F3, are potential responders to T + A combinations. We provide preliminary evidence that the FAD subtypes can be diagnosed based on liquid biopsies.

Conclusions::

We identified 3 FAD subtypes with unique clinical and biological characteristics, which could optimize individual cancer patient therapy and help clinical decision-making.

2024-01-01·Biochemical and biophysical research communications

Aurora-A inhibitor synergistically enhances the inhibitory effect of anlotinib on hepatocellular carcinoma

Article

作者: Wang, Rui ; Wang, Ting ; Lin, Xinrong ; Abudoureyimu, Mubalake ; Pan, Fan ; Hao, Liping

METHODS:

In this study, we used HCC cell lines to investigate whether the combination of the two drugs could enhance their individual strengths and mitigate their weaknesses, thereby providing greater clinical benefits both in vitro and in vivo.

RESULTS:

Our findings confirmed that the Aurora-A inhibitor alisertib and anlotinib exhibited a time-dose-dependent inhibitory effect on HCC cells. In vitro cytological experiments demonstrated that the combination of the two drugs synergistically inhibited cell proliferation, invasion, and metastasis, while promoting cell apoptosis. Furthermore, we identified the underlying molecular mechanism by which the combination of the Aurora-A inhibitor alisertib and anlotinib inhibited HCC through the inhibition of the NF-ĸB signaling pathway.

CONCLUSIONS:

In summary, we have demonstrated the effectiveness of combining anlotinib with an Aurora-A inhibitor, which expands the potential applications of anlotinib in the clinical treatment of HCC in the future.

2023-12-01·Bioorganic chemistry

A novel class of pyrazole analogues as aurora kinase A inhibitor: design, synthesis, and anticancer evaluation

Article

作者: Lalwani, Twinkle D ; Yevale, Digambar B ; Sangani, Chetan B ; Ameta, Rakesh Kumar ; Teraiya, Nishith

Pyrazole, as a small molecule, was discovered for higher cytotoxicity and affinity towards Aurora-A kinase. Based on these facts, a novel pyrazole substituted at the 4^th position was designed, synthesized, and evaluated against MCF-7, MDA-MB-23, and Vero (non-cancerous kidney cell) cell lines. Compounds5hand5eexhibited greater cytotoxicity in the series against MCF-7 and MDA-MB-231, with GI₅₀ values of 0.12 µM and 0.63 µM, respectively, as compared to Imatinib (GI₅₀ values of 16.08 µM and 10.36 µM). All of the compounds displayed selective cytotoxicity against cancer cells but not on normal Vero cells, supporting the design strategy to be a selective anticancer agent. Furthermore, compounds 5h and 5e inhibited Aurora-A kinase with IC₅₀ values of 0.78 µM (4.70-fold) and 1.12 µM (2.84-fold), respectively, as compared to alisertib (IC₅₀ = 3.36 µM). In addition, compound 5h significantly arrested the cell cycle at G2/M (34.89 %, 5.56-fold) and the apoptotic phase (25.04 %, 11.81-fold) compared to the control. It also triggered an increase in early (7.43 %) and late (14.89 %) phase apoptosis compared to vehicle (0.235 and 0.36 %, respectively), causing 37.89-fold higher total apoptosis in the annexin-V assay. These data imply that Aurora-A kinase inhibition may be linked to apoptosis induction and cell cycle arrest. Furthermore, their higher docking score in the study confirmed evidence of Aurora-kinase suppression. It was observed that fluorine and imidazole increased the H-bond and lipophilic interactions with the binding residue. Also, the substitution of electron-rich and lipophilic groups increased hydrophobic interactions. Moreover, the three-atom linkage (CH₂NHCH₂) expanded compound 5h to fill the cavity. Based on current findings, it is concluded that compounds 5h and 5e with strong Aurora-A kinase suppression may be promising anticancer agents.

项与 Alisertib 相关的新闻（医药）

2024-06-09

·药明康德

疾病控制率达100%的免疫联合疗法；使月度发作率下降98%的基因编辑疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 新型口服双重抑制剂TU2218联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者，在一项1b期临床试验中的疾病控制率（DCR）达100%。 2. 用于治疗遗传性血管水肿（HAE）的在研体内CRISPR基因编辑疗法NTLA-2002早期临床数据亮眼，单次给药后使患者的月度发作率平均下降了98%。 3. 现货型基因疗法PRGN-2012治疗复发性呼吸乳头状瘤病（RRP）患者的1/2期临床试验达到主要终点，有望成为首个获得FDA批准的用于治疗RRP的疗法。 4. 男性无激素避孕药YCT-529完成了1a期临床试验，在临床前研究中，该候选疗法预防小鼠妊娠的有效率为99%，且100%可逆。药明康德内容团队整理 TU2218：公布1b期临床试验的中期数据 TiumBio公司公布了新型口服双重抑制剂TU2218联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者1b期临床试验的中期结果。TU2218靶向转化生长因子β受体1（TGFR1）和血管内皮生长因子受体2（VEGFR2）。肿瘤微环境中的TGF-ß和VEGF通路会干扰免疫检查点抑制剂的抗肿瘤活性，因此TU2218有望通过抑制这两种通路最大限度地提高免疫疗法的疗效。此次公布的结果显示，5名接受2期推荐剂量（RP2D）TU2218联用pembrolizumab治疗的患者的DCR为100%，其中两名患者达到了部分缓解（PR），3名患者达到了疾病稳定（SD）。所有剂量组中，12名接受联合治疗的患者中有2人达到了PR，6人达到了SD。在这项研究中，TU2218联用pembrolizumab的耐受性良好，没有观察到剂量限制性毒性（DLT），这与之前的单药治疗试验一致。 NTLA-2002：公布1期临床试验的长期数据 Intellia Therapeutics公司宣布其用于治疗遗传性血管水肿的在研疗法NTLA-2002的1期临床试验的长期数据。NTLA-2002是一种体内CRISPR基因编辑候选疗法，通过脂质纳米颗粒（LNP）以mRNA形式递送CRISPR-Cas9基因编辑系统，靶向敲除血浆前激肽释放酶（KLKB1）基因，以永久性降低血浆中激肽释放酶活性，从而防止遗传性血管水肿的发作。此次公布的结果显示，中位随访时间为20.1个月时，单次NTLA-2002治疗让患者的月均疾病发作率平均减少了98%，中度至重度发作平均减少了99%。在测试的每个剂量水平上，HAE发作率均显著减少。单次输注后，患者最长的无发作期超过26个月，并且仍在持续。此外，100%接受NTLA-2002治疗的患者在停止其他预防性治疗后无需再进行预防性治疗。 PRGN-2012：公布1/2期临床试验的新数据 Precigen公司公布了其现货型基因疗法PRGN-2012治疗复发性呼吸乳头状瘤病患者的1/2期临床试验数据。PRGN-2012旨在激发对抗受HPV6或HPV11感染细胞的免疫反应，以治疗RRP。此前，PRGN-2012已获得FDA和欧盟委员会授予的孤儿药资格，还获得了FDA授予的突破性疗法认定。此次公布的结果显示，该1/2期临床试验达到了主要的安全性和疗效终点。中位随访时间为20个月时，51%（18/35）接受PRGN-2012治疗的患者达到了完全缓解（CR），且不再需要进行手术治疗，CR持续时间超过12个月。86%的患者在接受PRGN-2012治疗后的一年内需要进行的手术次数较治疗前一年减少，从治疗前一年的中位次数4次减少到接受治疗后的0次。此外，PRGN-2012显著改善了达到CR患者的Derkay评分（一种用于测量RRP生长程度的量表）和生活质量评分。安全性方面，PRGN-2012的耐受性良好，无DLT，也没有＞2级的治疗相关不良事件。 ▲PRGN-2012的1/2期临床试验结果（图片来源：参考资料[9]）该公司计划在2024年下半年通过加速批准途径提交PRGN-2012的滚动生物制品许可申请（BLA）。新闻稿指出，如果获得批准，PRGN-2012有可能成为首个获得FDA批准用于治疗RRP的疗法。 YCT-529：公布1a期临床试验数据 YourChoice Therapeutics公司公布其男性无激素避孕药YCT-529的1a期临床试验结果。YCT-529是一种视黄酸受体-α（RAR-a）抑制剂，通过阻断RAR-α来阻止睾丸中精子的产生和释放。临床前研究表明，YCT-529在预防小鼠妊娠方面有99%的有效性，且100%可逆。该研究的结果表明，YCT-529是安全的。 C-CAR031：公布1期临床试验的初步数据阿斯利康（AstraZeneca）公布其GPC3靶向CAR-T疗法C-CAR031的最新临床试验结果。GPC3是一种在肝癌中过表达的表面抗原，该蛋白在健康组织中几乎不存在。C-CAR031是一种GPC3靶向的自体CAR-T疗法，这款CAR-T疗法还同时“装备”了TGFβ以抵抗免疫抑制微环境，以增强其效力。此次公布的结果显示，中位随访时间为5.82个月时，22例可评估疗效的GPC3阳性晚期肝细胞癌（HCC）患者的DCR为90.9%，客观缓解率为50.0%，且该疗法的安全性可控。阿斯利康的早期肿瘤学开发负责人Matt Hellmann博士在接受行业媒体STAT采访时表示：“这是首个在肝癌治疗上显示具疗效的CAR-T疗法。这也是GPC3靶点的首次临床验证。” ▲C-CAR031的疗效结果摘要（图片来源：参考资料[1]） CB-010：公布1期临床试验数据 Caribou Biosciences公司公布了其同种异体CAR-T细胞疗法CB-010治疗复发/难治性B细胞非霍奇金淋巴瘤患者的新数据。CB-010利用基因编辑技术生成，除了表达靶向CD19的嵌合抗原受体，还利用基因编辑技术敲除了免疫检查点蛋白PD-1的表达，旨在提高抗肿瘤活性的持久性。截至2024年4月1日的数据，CB-010的疗效和安全性可与已获批的自体CAR-T细胞疗法相媲美。13名部分人类白细胞抗原（HLA）匹配（≥4个等位基因）患者的总缓解率达92%，CR率为46%，中位无进展生存期（PFS）获得改善，为14.4个月。 ▲接受CB-010治疗患者的无进展生存曲线（图片来源：参考资料[4]） ▲接受CB-010治疗患者的疗效结果（图片来源：参考资料[4]） INB-200：公布1期临床试验的新数据 IN8bio公司公布其耐化疗的转基因自体γδ T细胞疗法INB-200用于治疗新确诊的多形性胶质母细胞瘤的积极早期数据。INB-200是一种强大的协同治疗方法，能在患者接受化疗时持续存在，并保持其识别、参与和杀死癌细胞的自然能力。截至2024年5月30日的数据，中位随访时间为11.7个月，92%接受INB-200治疗的可评估患者的中位PFS超过了7个月（即接受标准治疗方案的患者的中位PFS）。一名患有IDH突变神经胶质瘤的患者在接受治疗后的34.9+个月时仍然存活，且疾病没有进展。近期发表的一项IDH抑制剂治疗IDH突变脑胶质瘤患者的临床试验中，对照组患者的中位PFS为11.1个月，试验组患者的中位PFS为28.5个月。安全性方面，在任何队列中均未报告与治疗相关的严重不良事件、DLT、细胞因子释放综合征、输注反应或免疫效应细胞相关神经毒性综合征。 IFx-2.0：公布1b期临床试验数据 TuHURA Biosciences公司公布了其个体化的候选癌症疫苗IFx-2.0治疗对免疫检查点抑制剂（ICI）耐药的晚期Merkel细胞癌（MCC）和皮肤鳞状细胞癌（cSCC）患者的1b期试验的初步结果。该候选疗法旨在克服患者对ICI的原发性耐药。此次公布的结果显示，连续三周每周给药一次IFx-2.0的耐受性良好。5名此前接受ICI治疗后在3.8个月内疾病就发生进展的晚期MCC患者中，有4人在接受IFx-2.0治疗后重新对ICI治疗产生了持久的应答，包括1例CR、1例病理完全缓解（pCR）和两例PR。患者的平均缓解时间为25个月，其中两名患者已分别持续缓解19个月和23个月，并且仍在持续缓解中。 MDNA11：公布1/2期临床试验的新数据 Medicenna Therapeutics公司公布了其下一代长效IL-2超级激动剂MDNA11治疗晚期实体瘤的新临床结果。MDNA11具有优秀的CD122（IL-2受体β）结合作用，而没有CD25（IL-2受体α）亲和力，从而能优先刺激癌症杀伤效应T细胞和NK细胞。此次公布的结果显示，MDNA11的耐受性良好，没有报告DLT和血管渗漏综合征。MDNA11在胰腺癌患者中表现出持久的缓解，1例转移性胰腺导管腺癌患者在基线时存在的所有病灶均完全消退，已维持超过104周，在停止治疗4个月后仍然保持着缓解。一例双检查点抑制剂治疗后进展的黑色素瘤患者的靶病灶在第28周时完全消退，在第44周的扫描时靶病灶仍保持完全消退。目前，该患者仍在接受MDNA11的治疗，非靶病灶也在继续消退。 WTX-124：公布1/1b期临床试验数据 Werewolf Therapeutics公司公布了其条件激活的白介素-2（IL-2）候选疗法WTX-124治疗接受过ICI治疗的局部晚期或转移性实体瘤患者的1/1b期临床试验数据。结果显示，WTX-124在此类患者中具有临床活性，且耐受性良好。截至2024年5月1日的数据，接受WTX-124单药治疗的患者中有1人获得了持久并经过确认的CR，2人达到了PR。获得缓解的患者在治疗的前两个治疗周期内就出现了缓解，并且靶病灶实现了100%的消退。此外，没有发现WTX-124联用pembrolizumab出现新的安全信号。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Retrieved June 4, 2024 from https://meetings.asco.org/abstracts-presentations/234377 [2] Virion Therapeutics Reports Positive First-in-human, First-in-class, Phase 1b Immunogenicity Data of VRON-0200, a Novel Checkpoint Modifier for HBV Functional Cure at EASL Congress. Retrieved June 5, 2024, from https://www.prnewswire.com/news-releases/virion-therapeutics-reports-positive-first-in-human-first-in-class-phase-1b-immunogenicity-data-of-vron-0200-a-novel-checkpoint-modifier-for-hbv-functional-cure-at-easl-congress-302161948.html [3] TiumBio Presents Phase 1b Interim Results for TU2218 in Combination with Pembrolizumab at ASCO 2024 Annual Meeting. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/tiumbio-presents-phase-1b-interim-results-for-tu2218-in-combination-with-pembrolizumab-at-asco-2024-annual-meeting-302160236.html [4] Caribou Biosciences Presents Encouraging Clinical Data from CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/02/2891868/0/en/Caribou-Biosciences-Presents-Encouraging-Clinical-Data-from-CB-010-ANTLER-Phase-1-Trial-in-Second-line-LBCL-Patients-at-the-2024-American-Society-of-Clinical-Oncology-ASCO-Annual-M.html [5] Werewolf Therapeutics to Present Data from Ongoing Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid Tumors. Retrieved June 7, 2024, from https://investors.werewolftx.com/news-releases/news-release-details/werewolf-therapeutics-present-data-ongoing-phase-11b-clinical [6] Medicenna To Present Evidence of Durable Single Agent Activity and Potent Immune Effector Response with MDNA11 in the Dose Escalation Portion of Phase 1/2 ABILITY-1 Study at the 10th Annual Oncology Innovation Forum. Retrieved June 7, 2024, from https://ir.medicenna.com/news-releases/news-release-details/medicenna-present-evidence-durable-single-agent-activity-and [7] Intellia Therapeutics Announces Positive Long-Term Data from Ongoing Phase 1 Study of NTLA-2002, an Investigational In Vivo CRISPR Gene Editing Treatment for Hereditary Angioedema (HAE). Retrieved June 3, 2024, from https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-announces-positive-long-term-data-ongoing [8] TuHURA Biosciences and Kintara Therapeutics Announce Positive Results from Phase 1b Trial of IFx-2.0, a Novel Personalized Cancer Vaccine, in Checkpoint Inhibitor Resistant Advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC). Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/tuhura-biosciences-and-kintara-therapeutics-announce-positive-results-from-phase-1b-trial-of-ifx-2-0--a-novel-personalized-cancer-vaccine-in-checkpoint-inhibitor-resistant-advanced-merkel-cell-carcinoma-mcc-and-cutaneous-squamo-302161301.html [9] Precigen Announces Groundbreaking Pivotal Study Data for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis in Which More than Half of Patients Achieved Complete Response. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/precigen-announces-groundbreaking-pivotal-study-data-for-prgn-2012-in-patients-with-recurrent-respiratory-papillomatosis-in-which-more-than-half-of-patients-achieved-complete-response-302161493.html [10] YourChoice Therapeutics Completes Phase 1a Clinical Study for First Hormone-Free Male Birth Control Pill. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603886060/en/ [11] IN8bio Presents Progression-Free Survival Update from Phase 1 Study of INB-200 at 2024 American Society of Clinical Oncology Annual Meeting. Retrieved June 7, 2024, from https://investors.in8bio.com/news-releases/news-release-details/in8bio-presents-progression-free-survival-update-phase-1-study [12] 4DMT Presents Positive Interim Data from Phase 1/2 AEROW Clinical Trial of Aerosolized 4D-710 for Modulator-Ineligible/-Intolerant Cystic Fibrosis at 47th European Cystic Fibrosis Conference. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/06/2894575/0/en/4DMT-Presents-Positive-Interim-Data-from-Phase-1-2-AEROW-Clinical-Trial-of-Aerosolized-4D-710-for-Modulator-Ineligible-Intolerant-Cystic-Fibrosis-at-47th-European-Cystic-Fibrosis-C.html [13] Mythic Therapeutics Presents Initial Dose Escalation Data from Ongoing Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603700748/en [14] Syndax Announces Plans to Advance into Phase 1b Portion of Trial Evaluating Revumenib in Relapsed or Refractory Metastatic MSS CRC. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/syndax-announces-plans-to-advance-into-phase-1b-portion-of-trial-evaluating-revumenib-in-relapsed-or-refractory-metastatic-mss-crc-302165405.html [15] BridgeBio Oncology Therapeutics announces first patient dosed with BBO-8520 in the Ph. 1 ONKORAS-101 trial for KRASG12C NSCLC. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240606977682/en/ [16] Vivet Therapeutics Presents Interim Data from its Phase 1/2 GATEWAY Trial for the Treatment of Wilson Disease at EASL Congress 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/vivet-therapeutics-presents-interim-data-from-its-phase-12-gateway-trial-for-the-treatment-of-wilson-disease-at-easl-congress-2024-302164666.html [17] Altimmune Presents Data at EASL International Liver Congress™ 2024 Supporting the Disease Modifying Potential and Differentiated Therapeutic Profile of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH). Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/6/5/2893731/0/en/Altimmune-Presents-Data-at-EASL-International-Liver-Congress-2024-Supporting-the-Disease-Modifying-Potential-and-Differentiated-Therapeutic-Profile-of-Pemvidutide-in-Metabolic-Dysf.html [18] Quell Therapeutics Advances QEL-001, its Multi-modular Engineered CAR-Treg Cell Therapy, into Efficacy Cohort of LIBERATE Phase 1/2 Trial in Liver Transplant Patients. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2893353/0/en/Quell-Therapeutics-Advances-QEL-001-its-Multi-modular-Engineered-CAR-Treg-Cell-Therapy-into-Efficacy-Cohort-of-LIBERATE-Phase-1-2-Trial-in-Liver-Transplant-Patients.html [19] Surrozen Initiates Dosing of First Patient in Phase 1b Clinical Trial of SZN-043 for Severe Alcohol-Associated Hepatitis. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2893050/0/en/Surrozen-Initiates-Dosing-of-First-Patient-in-Phase-1b-Clinical-Trial-of-SZN-043-for-Severe-Alcohol-Associated-Hepatitis.html [20] Cue Biopharma Presents Updated Data from Phase 1 Trial of CUE-101 in Recurrent/Metastatic HPV+ Head and Neck Cancer at the 2024 ASCO Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2892974/0/en/Cue-Biopharma-Presents-Updated-Data-from-Phase-1-Trial-of-CUE-101-in-Recurrent-Metastatic-HPV-Head-and-Neck-Cancer-at-the-2024-ASCO-Annual-Meeting.html [21] Merus Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab at the 2024 ASCO® Annual Meeting. Retrieved June 7, 2024, from https://ir.merus.nl/news-releases/news-release-details/merus-presents-interim-data-mcla-145-monotherapy-and-combination [22] BlueSphere Bio Announces IND Clearance of its First in Human Candidate and New Cell Therapy Portfolio for High-Risk Leukemia Patients. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892552/0/en/BlueSphere-Bio-Announces-IND-Clearance-of-its-First-in-Human-Candidate-and-New-Cell-Therapy-Portfolio-for-High-Risk-Leukemia-Patients.html [23] Grey Wolf Therapeutics Presents First Clinical Data for GRWD5769, a First-in-Class ERAP1 Inhibitor, at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/grey-wolf-therapeutics-presents-first-clinical-data-for-grwd5769-a-first-in-class-erap1-inhibitor-at-the-2024-american-society-for-clinical-oncology-asco-annual-meeting-302161297.html [24] Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603691086/en [25] Cyclacel Pharmaceuticals Reports New Clinical Data at 2024 ASCO Annual Meeting Highlighting Oral Fadraciclib’s Potential as a Precision Medicine for Cancer. Retrieved June 7, 2024, from https://investor.cyclacel.com/news-releases/news-release-details/cyclacel-pharmaceuticals-reports-new-clinical-data-2024-asco [26] Obsidian Therapeutics Announces Additional OBX-115 Safety and Efficacy Data in Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603008329/en [27] Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://ir.replimune.com/news-releases/news-release-details/replimune-presents-rp1-data-ignyte-anti-pd1-failed-melanoma [28] RS Oncology Announces Positive Data from a Phase 1 Clinical Trial of RSO-021, a First-in-Class Therapeutic for Malignant Pleural Mesothelioma. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603559175/en [29] Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892565/0/en/Ascendis-Pharma-Presents-New-Data-and-Updated-Results-from-Phase-1-2-IL-Believe-Trial-at-ASCO-2024.html [30] Scholar Rock Presents New Data from SRK-181 Phase 1 DRAGON Trial at ASCO 2024 Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603004778/en [31] invoX Pharma Presents Positive Clinical Data from Phase 1 Study of FS222 in Patients with Advanced Solid Tumours at the 2024 American Society of Clinical Oncology Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603068133/en [32] Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892558/0/en/Eledon-Presents-Updated-Data-from-Ongoing-Phase-1b-Trial-Evaluating-Tegoprubart-for-Prevention-of-Rejection-in-Kidney-Transplantation.html [33] ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603017832/en [34] Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892199/0/en/Entera-Bio-Reports-Phase-1-Clinical-Data-of-First-in-Class-Oral-PTH-1-34-Peptide-Candidate-EB612-for-Patients-with-Hypoparathyroidism-at-ENDO-2024.html [35] Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892206/0/en/Enlivex-Receives-Regulatory-Authorization-for-the-Initiation-of-a-Placebo-Controlled-Phase-I-II-Trial-Evaluating-Allocetra-in-Up-To-46-Patients-with-Thumb-Osteoarthritis.html [36] Indaptus Therapeutics Announces New Positive Data from Ongoing Phase 1 Trial of Decoy20. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892212/0/en/Indaptus-Therapeutics-Announces-New-Positive-Data-from-Ongoing-Phase-1-Trial-of-Decoy20.html [37] Alkermes Presents Data From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 1 at SLEEP 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/alkermes-presents-data-from-phase-1b-study-of-alks-2680-demonstrating-improved-wakefulness-in-patients-with-narcolepsy-type-1-at-sleep-2024-302161336.html [38] IDRx Reports Updated Preliminary Phase 1 Data from Ongoing Phase 1/1b StrateGIST 1 Trial Supporting Best-in-Class Potential for IDRX-42 in Patients with GIST. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240531639390/en [39] Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892097/0/en/Century-Therapeutics-Presents-Interim-Results-from-Phase-1-ELiPSE-1-Study-at-ASCO-2024-Annual-Meeting.html [40] MediciNova Announces Data from Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma Patients at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892064/7767/en/MediciNova-Announces-Data-from-Phase-1b-2a-Clinical-Trial-of-MN-166-ibudilast-in-Glioblastoma-Patients-at-the-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting-2024.html [41] FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892568/0/en/FibroGen-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-FG-3165-a-Galectin-9-Targeting-Monoclonal-Antibody-for-the-Treatment-of-Patients-with-Solid-Tumors.html [42] STORM Therapeutics Presented Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/storm-therapeutics-presented-interim-phase-1-clinical-data-on-its-mettl3-rna-methyltransferase-inhibitor-stc-15-at-asco-2024-302160864.html [43] Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-presents-promising-bdtx-1535-clinical [44] Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/05/31/2891735/0/en/Immunocore-reports-updated-Phase-1-data-of-brenetafusp-IMC-F106C-an-ImmTAC-bispecific-targeting-PRAME-in-immune-checkpoint-pre-treated-cutaneous-melanoma-patients-at-ASCO-2024.html [45] Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/01/2891812/0/en/Kymera-Therapeutics-Presents-New-Clinical-Data-from-Ongoing-Phase-1-Trial-of-MDM2-Degrader-KT-253-at-ASCO-Annual-Meeting.html [46] Accutar Biotechnology Presents Phase 1 Data of AC699 Monotherapy in Patients with ER+ / HER2- Breast Cancer at ASCO 2024. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240601126229/en [47] Molecular Partners Presents Positive Data From Completed Phase 1 Trial Of MP0317 (FAP X CD40 DARPin) Monotherapy In Patients With Advanced Solid Tumors At ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/01/2891809/0/en/Molecular-Partners-Presents-Positive-Data-From-Completed-Phase-1-Trial-Of-MP0317-FAP-X-CD40-DARPin-Monotherapy-In-Patients-With-Advanced-Solid-Tumors-At-ASCO-2024.html [48] Updated Data from the Phase 1/2 Study of Olomorasib in KRAS G12C-Mutant Advanced Solid Tumors Presented at the 2024 ASCO® Annual Meeting. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/updated-data-from-the-phase-12-study-of-olomorasib-in-kras-g12c-mutant-advanced-solid-tumors-presented-at-the-2024-asco-annual-meeting-302160829.html [49] ALX Oncology Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 ASPEN-07 Clinical Trial in Patients with Advanced Bladder Cancer. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/02/2891851/0/en/ALX-Oncology-Presents-First-Evorpacept-Combination-Data-with-an-Antibody-Drug-Conjugate-from-Phase-1-ASPEN-07-Clinical-Trial-in-Patients-with-Advanced-Bladder-Cancer.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果基因疗法免疫疗法临床2期

2024-06-07

·BioSpace

Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - June 07, 2024

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on June 6, 2024, the Compensation Committee of Puma’s Board of Directors approved the grant of an inducement restricted stock unit award covering 3,500 shares of Puma common stock to one new non-executive employee. The award was granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit award vests over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, June 1, 2024, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The award was granted as an inducement material to the new employee entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. View source version on businesswire.com: Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com Source: Puma Biotechnology, Inc. View this news release online at:

上市批准引进/卖出临床2期

2024-06-03

·BioSpace

Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of alisertib for the treatment of patients with advanced osimertinib-resistant epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NCT04085315) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting currently being held in Chicago. The poster (Abstract #8572, Poster Bd #436), entitled, “A Phase I/Ib study of the aurora kinase A inhibitor alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer,” was presented by Turja Chakrabarti, MD., University of California, San Francisco, at the Lung Cancer – Non-Small Cell Metastatic Poster Session, on June 3 at 1:30 p.m. CDT. A copy of the poster is available on the Puma website. This open-label, single-center Phase I/Ib study enrolled 21 evaluable patients with stage IV EGFR-mutated NSCLC (EGFR driver mutation: 76.1% exon 19 deletion; 14.3% L858R; 9.5 % L861Q) who had progressed on osimertinib monotherapy. 47.6% of patients had previously received only first-line osimertinib monotherapy, while 52.3% had received two or greater prior lines of therapy. In the Phase I portion of the trial, 10 patients were treated in a 3+3 dose escalation phase with alisertib using an intermittent dosing strategy of 30 mg (n = 6) or 40 mg (n = 4) twice daily (BID) in combination with osimertinib 80 mg daily. Alisertib was added to osimertinib treatment at the time of disease progression on osimertinib. Intermittent alisertib 30 mg BID was identified as the MTD and RP2D in combination with osimertinib 80 mg daily. In the Phase Ib expansion portion of the trial, 11 additional patients were treated at the 30 mg alisertib BID intermittent dosing schedule in combination with osimertinib 80 mg daily with alisertib being added to osimertinib treatment at the time of disease progression on osimertinib. The most common treatment-related adverse events (AEs) (any grade) included neutropenia (42.9%), anemia (42.9%), diarrhea (38.1%), and lymphopenia (33.3%). Grade 3 or higher AEs neutropenia (4.8%), anemia (4.8%), diarrhea (14.3%), and lymphopenia (4.8%). For the 21 evaluable patients, the investigator assessed overall response rate was 9.5% (95% CI: 0 to 22%) and disease control rate was 81% (95% CI: 69% to 93%). The median PFS for all patients was 5.5 months, while the median OS was 23.5 months. For patients with TP53 mutations (n=9), the overall response rate was 0%, and the disease control rate was 66.7%. For patients who were tp53 wild type (n=8), the overall response rate was 25%, and the disease control rate was 87.5%. For patients with TP53 mutations, the progression free survival was 3.7 months, and for patients who were tp53 wild type, the progression free survival was 8.0 months (hazard ratio:0.42, p = 0.05). Dr. Collin M. Blakely, the lead principal investigator of the study and senior author of the presentation, from the University of California in San Francisco, said, “We are pleased with the initial results of the clinical trial and very interested in the cohort of patients who are tp53 wild type as tp53 is known to be involved in the aurora kinase pathway. We are modifying the protocol to limit further enrollment in the trial to patients who are tp53 wild type and we look forward to further studying this combination in this biomarker directed cohort of patients.” Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are pleased to see the promising efficacy signals in the cohort of patients who are tp53 wild type. As tp53 is well known to be involved in the aurora kinase pathway, we are pleased to see the activity of alisertib when given in combination with osimertinib in this population of patients. We look forward to continuing to enroll this trial in this cohort of patients.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. Further information about Puma Biotechnology may be found at . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and the development of alisertib. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the U.S. Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

临床1期临床结果上市批准引进/卖出ASCO会议

100 项与 Alisertib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10085	Alisertib	-	DB05220

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
难治性外周T细胞不明淋巴瘤	临床3期	美国	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	澳大利亚	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	奥地利	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	白俄罗斯	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	比利时	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	巴西	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	保加利亚	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	加拿大	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	智利	Millennium Pharmaceuticals, Inc.	2012-06-11
难治性外周T细胞不明淋巴瘤	临床3期	捷克	Millennium Pharmaceuticals, Inc.	2012-06-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04085315 (phase I/Ib study, ASCO2024) 人工标引	临床1期	EGFR突变肺癌 EGFR	21	alisertib+osimertinib	廠鹽範廠餘遞廠廠窪願(遞壓蓋醖醖繭積鹽齋糧) = neutropenia (42.9%), anemia (42.9%), and diarrhea (38.1%) 廠壓範衊簾夢夢糧願夢 (築艱鹹鹽簾淵顧構願簾 )	积极	2024-05-24
NCT02860000 (TBCRC041, ASCO2024)	临床2期	转移性乳腺癌 ESR1 \| PIK3CAmutation \| AKT1 ... 更多	91	Alisertib + Fulvestrant	蓋遞積鑰餘遞淵鏇廠廠(鏇窪範觸鹹範鹹積網積): HR = 1.8 (95% CI, 1.1 ~ 2.9), P-Value = 0.014	积极	2024-05-24
NCT02860000 (TBCRC041, ASCO2024)	临床2期	转移性乳腺癌 ESR1 \| PIK3CAmutation \| AKT1 ... 更多	91	Alisertib		积极	2024-05-24
NCT02187991 (ASCO2023)	临床2期	HER2 阴性乳腺癌	96	Alisertib+Paclitaxel	選艱憲選淵網醖膚壓壓(築積鑰鹹衊壓壓膚鹹艱) = 襯鑰襯糧醖膚繭壓積鹹鬱壓糧蓋淵鏇膚醖製範 (繭遞鹽壓蓋願夢鬱淵壓 )	积极	2023-05-31
NCT02860000 (Pubmed)	临床2期	晚期乳腺癌 CDK 4/6i	91	Alisertib	繭鏇製選鹹願鹽願蓋鹽(蓋鏇網願窪壓膚遞齋製) = 網遞艱構鏇膚範壓鹹獵壓鏇顧壓簾鑰壓獵願簾 (觸蓋蓋鬱觸膚網獵鹽鏇, 29.0% ~ 54.5%) 更多	-	2023-03-09
NCT02860000 (Pubmed)	临床2期	晚期乳腺癌 CDK 4/6i	91	Alisertib + Fulvestrant	繭鏇製選鹹願鹽願蓋鹽(蓋鏇網願窪壓膚遞齋製) = 願鬱衊網範製構衊簾壓壓鏇顧壓簾鑰壓獵願簾 (觸蓋蓋鬱觸膚網獵鹽鏇, 18.0% ~ 42.0%) 更多	-	2023-03-09
NCT02293005 (CTgov)	临床2期	恶性间皮瘤	28	Alisertib	壓顧製製構餘網糧窪齋(鑰艱鹽簾鹽衊鏇齋廠夢) = 糧膚鏇齋壓襯選廠繭廠範鹹範膚選繭艱壓積簾 (淵衊製夢築獵壓夢網顧, 構夢膚遞網願壓壓餘觸 ~ 鹹觸鹽構糧廠顧鏇願淵) 更多	-	2022-10-04
NCT01924260 (Pubmed) 人工标引	临床1期	HR阳性/HER2低表达实体瘤 \| 胰腺癌	26	Alisertib+Gemcitabine	鬱衊築願齋願顧鬱願觸(獵夢鬱艱衊壓夢衊網鏇) = 簾蓋構糧壓製觸製選衊構顧觸鹹獵遞鏇壓鬱獵 (廠淵範顧構鑰遞願遞糧, 2.1 ~ 4.5) 更多	积极	2022-07-30
NCT02114229 (SJATRT, Pubmed) 人工标引	临床2期	中枢神经系统横纹肌瘤	30	alisertib	積蓋獵壓簾壓顧衊選觸(糧繭蓋窪艱壓蓋製餘築) = 製餘範醖遞網願蓋選積艱範憲製簾築願糧製窪 (繭壓鑰顧範顧膚範襯選, 5.6) 更多	不佳	2022-06-02
NCT02719691 (ASCO2022)	临床1期	HR阳性/HER2低表达实体瘤	31	Alisertib + MLN0128	鹹製衊鹹壓廠築鬱鏇鏇(築衊簾餘鏇範遞襯網獵) = mucositis, fatigue, hyperglycemia and neutropenia reported as most common 顧鑰製構遞淵襯遞繭簾 (製獵廠築醖觸網憲壓繭 )	-	2022-06-02
NCT04479306 (ASCO2022)	临床1期	复发性非小细胞肺癌	40	Osimertinib 80 mg daily + Alisertib 20 mg, 30 mg, and 40 mg daily	遞窪衊鏇鹽積築廠繭遞(窪獵鹹糧鹹選鹹醖願廠) = Biomarker analysis is ongoing to identify the molecular determinants of response and resistance to sapasertib 鑰鏇鑰艱觸繭糧鹹鹹鑰 (製餘餘餘餘鹹衊鹹廠獵 ) 更多	-	2022-06-02
NCT04479306 (ASCO2022)	临床1期	复发性非小细胞肺癌	40	Osimertinib 80 mg daily + Sapanisertib 2 mg and 3 mg daily		-	2022-06-02
NCT02719691 (CTgov)	临床1期	晚期恶性实体瘤 \| 转移性乳腺癌 \| 转移性三阴性乳腺癌	47	Alisertib+MLN0128 (Dose Level 4: Alisertib 40 mg/MLN0128 3 mg)	衊願鏇憲壓壓築廠醖壓(範構糧獵構蓋廠築鏇蓋) = 淵廠膚淵齋餘憲鹽鏇糧繭窪願築餘構壓壓選壓 (獵遞糧鬱蓋網膚獵衊鹽, 鹽廠簾蓋網鏇鏇鬱壓壓 ~ 憲膚憲餘壓繭衊築獵構) 更多	-	2022-01-19
NCT02719691 (CTgov)	临床1期	晚期恶性实体瘤 \| 转移性乳腺癌 \| 转移性三阴性乳腺癌	47	Alisertib+MLN0128 (Pancreatic Cohort)	鬱鏇願獵廠衊窪鹹獵鬱(願鏇淵積鏇憲鏇襯製鹹) = 膚艱繭蓋簾獵築簾淵鑰窪夢獵繭蓋製網構憲築 (觸膚繭衊獵獵鹹淵窪簾, 糧製夢遞艱鏇遞淵餘選 ~ 餘齋襯憲遞遞窪顧憲鏇) 更多	-	2022-01-19