A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

开始日期2025-06-02

申办/合作机构

AbbVie, Inc.

NCT06627751

/ Not yet recruiting临床2期IIT

Phase II Clinical Trial of Mezigdomide/Carfilzomib/Dexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)

This phase II trial studies how well mezigdomide/carfilzomib/dexamethasone (MeziKD) works in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and have tumors from myeloma cells outside the bone marrow in the soft tissues or organs of the body (extramedullary disease [EMD]). Mezigdomide blocks important processes in myeloma cells and may lead to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a type of corticosteroid and is used to kill myeloma cells. It is used with other drugs to treat multiple myeloma. Giving MeziKD may kill more cancer cells in patients with relapsed/refractory multiple myeloma (RRMM) with EMD.

开始日期2025-04-01

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT06622005

/ Recruiting临床1期IIT

Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become "free" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma

开始日期2025-04-01

申办/合作机构

Roswell Park Comprehensive Cancer Center

100 项与卡非佐米相关的临床结果

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100 项与卡非佐米相关的转化医学

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100 项与卡非佐米相关的专利（医药）

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2,528

项与卡非佐米相关的文献（医药）

2025-04-01·CLINICAL MICROBIOLOGY AND INFECTION

Phenotypic and genotypic correlates of the sodium bicarbonate-responsive phenotype among methicillin-resistant Staphylococcus aureus isolates from skin and soft-tissue infections

Article

作者: Madrigal, Sabrina L ; Proctor, Richard A ; Ersoy, Selvi C ; Xiong, Yan Q ; Blane, Beth ; Flores, Evelyn A ; Chambers, Henry F ; Harrison, Ewan M ; Chen, Liang ; Bayer, Arnold S ; Mediavilla, Jose ; Peacock, Sharon J ; Kreiswirth, Barry ; Patel, Robin ; Miller, Loren G

OBJECTIVES:

The objective of this study is to assess the frequency of the novel sodium bicarbonate (NaHCO₃)-responsive phenotype, wherein clinical methicillin-resistant Staphylococcus aureus (MRSA) isolates are rendered susceptible to standard-of-care β-lactams in the presence of NaHCO₃, in a collection of 103 clinical U.S. MRSA skin and soft-tissue infection (SSTI) isolates and 22 clinical European SSTI isolates. This study determined the correlation between specific phenotypic and genotypic metrics and the NaHCO₃-responsive phenotype among U.S. SSTI isolates.

METHODS:

Antimicrobial susceptibility testing was performed to determine susceptibility phenotypes. Targeted and whole-genome sequencing with a genome-wide sequence analysis were conducted to identify specific and novel genotypes of interest that may be associated with the NaHCO₃-responsive phenotype. Gene expression analysis and targeted gene deletion were performed to assess the role of a specific novel genetic locus in the NaHCO₃-responsive phenotype.

RESULTS:

The NaHCO₃-responsive phenotype was identified in 78/103 U.S. isolates and 4/22 UK isolates to cefazolin (CFZ), and in 17/103 U.S. isolates and 1/22 UK isolates to oxacillin. In U.S. isolates, a significant association was identified between NaHCO₃-responsiveness to CFZ and: (a) susceptibility to amoxicillin-clavulanate; (b) a specific mecA genotype; (c) clonal complex type 8; and (d) spa type t008. Genome-wide sequence analysis identified single nucleotide polymorphisms (SNPs) in an AraC family regulator (SAUSA300_RS00540) to be exclusively found in NaHCO₃-non-responsive SSTI strains. In vitro HCO₃ exposures of NaHCO₃-responsive strains, but not -non-responsive strains, caused >2-fold upregulated expression of this gene. Deletion of this gene rendered NaHCO₃-responsive strain MRSA 11/11 no longer NaHCO₃-responsive to CFZ; we have termed this gene the staphylococcal AraC bicarbonate-response regulator.

DISCUSSION:

NaHCO₃-responsiveness is highly associated with clonal complex type 8/spa type t008, a commonly circulating genetic background in North America. The AraC bicarbonate-response regulator, staphylococcal AraC bicarbonate-response regulator, appears to be associated with the mechanism of NaHCO₃-responsiveness, but more work is needed to verify.

2025-03-25·Microbiology Spectrum

Diagnostic accuracy of direct drug susceptibility testing of second-line antitubercular drugs.

Article

作者: Srivastava, Kartiki ; Raikwar, Vinod Kumar ; Anupurba, Shampa ; Singh, Varsha

IMPORTANCE:

The significance of this work is that it assesses whether direct drug susceptibility could be used in routine testing to save significant time, which is critical for early diagnosis of resistance and successful treatment.

2025-03-01·Transplantation and Cellular Therapy

Outcomes of Standard-Risk Multiple Myeloma Patients Who Undergo Upfront Autologous Hematopoietic Stem Cell Transplantation

Article

作者: Kebriaei, Partow ; Aljawai, Yosra ; Lee, Hans C ; Ye, Christine ; Wang, Zhongya ; Champlin, Richard E ; Milton, Denái R ; Nieto, Yago ; Lin, Paul ; Qazilbash, Muzaffar H ; Ramdial, Jeremy ; Pal, Babar ; Srour, Samer ; Tang, Guilin ; Patel, Krina K ; Pasvolsky, Oren ; Marcoux, Curtis ; Becnel, Melody R ; Thomas, Sheeba K ; Tanner, Mark R ; Orlowski, Robert Z ; Bashir, Qaiser ; Saini, Neeraj ; Shpall, Elizabeth J ; Syed, Naureen

Patients with multiple myeloma (MM) without high-risk cytogenetic abnormalities are classified as having standard-risk MM (SRMM), and data focusing on their outcomes after autologous hematopoietic stem cell transplantation (autoHCT) are limited. We sought to evaluate survival outcomes for patients with SRMM receiving autoHCT, and to elucidate factors that impact these outcomes. This was a single-center retrospective analysis that included consecutive MM patients who received upfront autoHCT between 2013 and 2021, had available cytogenetic information and had no high-risk chromosomal abnormalities on fluorescence in situ hybridization, defined as t(4;14), t(14;16), del(17p) or 1q21 gain or amplification. A total of 1000 SRMM patients were included, with a median age of 61 years (range 25 to 83), and 61% were male (n = 612). The most common induction regimens were bortezomib/lenalidomide/dexamethasone (VRD; n = 398, 40%) and carfilzomib/lenalidomide/dexamethasone (KRD; n = 212, 21%), and the majority (87%) received single-agent melphalan as conditioning. After induction and before autoHCT, 16% and 57% achieved ≥complete response (CR) and ≥very good partial response (VGPR), respectively. At day 100 post autoHCT, 37% and 77% achieved ≥CR and ≥VGPR, respectively. Sixty-two percent and 89% of patients achieved ≥ CR and ≥VGPR as best response post-transplant. A minimal residual disease (MRD) negative response pre- and post-transplantation was achieved in 43% (401/936) and 64% (199/311) of patients, respectively. After a median follow-up of 42.1 months, the median progression-free survival (PFS) for the entire cohort was 68.3 months (95% CI 60.1 to 72.1), and the median overall survival (OS) was not reached (95% CI 102.3-not reached). The 5-year PFS and OS rates were 55% and 83%, respectively. In multivariable analysis, achieving MRD-negative CR prior to autoHCT (HR 0.65 [95% CI 0.44 to 0.97], P = .033) or as best response (0.52 [0.34 to 0.78], P = .002), and use of post-transplant maintenance (0.69 [0.52 to 0.93], P = .013) and lenalidomide-based combination maintenance (0.68 [0.48 to 0.96], P = .030) were associated with improved PFS, whereas use of an induction regimen other than KRD was associated with worse PFS (1.50 [1.04 to 2.17], P = .031). For OS, post-transplant maintenance (0.48 [0.32 to 0.70], P < .001) was associated with better survival in multivariable analysis, whereas R-ISS stage III, compared with stage I, (2.34 [1.01 to 5.43], P = .047) was associated with worse OS. Patients with SRMM who received upfront autoHCT had a median PFS of >5.5 years, and median OS was not reached. These results highlight the favorable outcomes with upfront autoHCT for patients with SRMM, serving as a benchmark for future therapeutic approaches in this subgroup of MM patients.

394

项与卡非佐米相关的新闻（医药）

2025-03-26

·智药邦

Nat Rev Drug Discov｜药物再利用的计算：方法、体外资源评估及案例研究

2025年3月18日，来自赫尔辛基大学等机构的研究人员在Nature Reviews Drug Discovery发表了题为Computational drug repurposing: approaches, evaluation of in silico resources and case studies的综述文章。文章全面综述了药物再利用的计算方法，并使用专门构建的药物再利用本体论(ontology)对资源进行分类，介绍了特定的应用。文章还展示了对选定资源的专家评估以及在全球健康紧急情况研究计划（REMEDi4ALL）项目中实施的三个药物再利用案例研究，以展示资源的实际应用。药物开发的高成本与长周期已成为全球医疗创新的主要瓶颈。据统计，单个新药从实验室到上市平均需投入26亿美元，耗时10-15年。在此背景下，药物再利用（Drug Repurposing）作为突破性策略应运而生。该策略通过挖掘已获批药物或临床阶段化合物的新适应症，可将研发成本降低60%，时间缩短至3-12年。典型案例包括西地那非从心绞痛治疗转向勃起功能障碍，以及沙利度胺从镇静剂转型为多发性骨髓瘤治疗药物。这种策略的成功依赖于两大核心要素：首先，已有人体安全性数据可规避早期临床试验风险；其次，现代计算生物学技术为快速识别潜在靶点提供可能。随着人工智能、多组学整合分析等技术的突破，药物重定位已从偶然发现转向系统化研究。例如，REMEDi4ALL等欧盟旗舰项目正通过构建包含181种计算资源的智能平台，推动该领域向数据驱动模式转型。图1 药物再利用本体论计算药物再利用方法基于靶点的药物再利用方法基因组学分析：PharmGWAS整合近2000项GWAS研究，建立基因变异-药物响应关联网络。临床基因组数据库（ClinVar）与gnomAD提供超过76万例基因组数据，支持罕见病靶点发现。DisGeNET收录百万级基因-疾病关联数据，通过证据等级评估助力靶点优先级排序。结构模拟技术：分子对接技术通过模拟药物-靶点结合构象预测相互作用，ChemSpider与ZINC提供化合物结构库，AlphaFold v3实现高精度蛋白结构预测。PyMol等可视化工具辅助结合位点分析，多算法融合提升预测可靠性。生化数据库应用：PubChem与ChEMBL分别收录450万和200万条生物活性数据，支持虚拟筛选。Reactome数据库整合1.5万条生物通路信息，KEGG用于构建疾病特异性基因网络，如加巴喷丁在帕金森病中的潜在应用预测。表型药物再利用方法细胞模型筛选：DepMap通过CRISPR筛选建立癌细胞系基因依赖性图谱，PRISM平台实现药物敏感性分析。NCATS药物库在疾病模型中进行高通量筛选，发现利托那韦的肌张力障碍治疗潜力。SynergyFinder工具解析药物组合协同效应，支持复杂疾病机制干预。转录组特征匹配：Connectivity Map（CMap）收录1.3万种化合物在COVID-19相关细胞中的L1000表达谱，通过特征相似性预测作用机制。案例显示，肺腺癌细胞系特征与TGF-β通路抑制剂的匹配率达82%。药物-疾病关联挖掘：DrugCentral 2023整合全球监管数据，涵盖4.8万项临床试验信息。CTD数据库建立10万+化合物-疾病关联，DrugRepo通过化学-基因组评分系统预测新适应症。临床级数据平台cBioPortal支持TCGA多组学数据可视化，发现TGFβ抑制剂在衰老相关疾病中的潜力。安全性评估体系：SIDER数据库记录5868种药物不良反应，OnSIDES通过NLP技术提取药品说明书信息。DrugBank整合100万+药物相互作用数据，CompTox提供化学品毒性预测模型。诺华次要药理学数据库系统解析脱靶效应，支持安全性优化。真实世界数据应用：TCGA与GENIE提供肿瘤基因组-临床结局关联数据，GTEx建立健康组织表达基线。EHDS框架推动欧洲健康数据共享，CURE ID平台实现治疗案例众包分析，加速罕见病药物发现。表1 |基于靶点和表型的药物再利用方法总结预测模型开发 Therapeutics Data Commons提供AI训练数据集，支持毒性预测模型开发。深度学习模型通过迁移学习降低临床前数据需求，scTherapy工具结合单细胞转录组定制个体化方案。BioModels平台托管可复现的药理模型，推动计算预测向实验验证转化。资源的分类和专家评估为了开始构建药物再利用目录并实现对当前和新兴的计算资源的专家评估，研究首先设计了一个独特的药物再利用本体，将资源分为两大类、七个子类别和15个亚子类别，分为三个应用特定级别。基于调查，研究还在目录中添加了三个更广泛的类别：预测方法、基于网络的预测工具和基于GUI的数据挖掘工具。在专家评估中，27位在计算、实验和临床分析方面具有广泛专业知识的专家对每个类别中的资源进行了排名，并提供了0（最差）到10（最佳）之间的评分。评估是在两轮中进行的，导致对181个计算资源进行了评分和注释。案例研究 SARS-CoV-2治疗的新药物组合对5275种化合物进行三重表型筛选，获得317个活性分子（含77种已上市药物）。通过DrugComb数据库识别balicatib/阿莫地喹协同组合，经LINCS L1000分析筛选出821对表型-结构多样性组合。靶点富集发现ALDH1A1等4个高表达靶点，双硫仑/卡非佐米组合进入临床前验证阶段。图2 针对SARS-CoV-2的协同药物组合的再利用胰腺癌中的丙戊酸-辛伐他汀组合基于辛伐他汀与丙戊酸的协同抗肿瘤机制，通过ChEMBL等数据库识别15个共同靶点。KEGG分析揭示AMPK通路双重调控机制，UGT1A1代谢相互作用经DrugBank验证。VigiBase等安全数据库显示组合治疗未增加不良反应风险，支持其进入III期临床试验（NCT05821556）。图3 辛伐他汀和丙戊酸联合治疗转移性胰腺导管腺癌的特征结论和未来方向计算药物再利用资源应用的主要挑战在于，为现有药物提取新靶点或适应症所需的机制和表型信息分散在越来越多的数据库和预测平台中，这些平台提供的信息在覆盖范围、质量和可靠性方面各不相同。作者与REMEDi4ALL项目合作伙伴和外部专家一起，调查了181种当前可用且广泛使用的工具、数据库和预测方法。未来的工作需要社区范围内的共同努力，以维持和发展一个可持续和最新的网络资源库，帮助选择在实施特定再利用应用时的正确资源。社区成员可以使用网站上的反馈选项添加新资源或建议对现有资源或注释进行修改。药物再利用领域仍在发展中，特别是对于基于AI的工具，每周都有新的资源被开发出来，可能对药物再利用有用。因此，需要社区范围内的方法来编目、评估和注释，以维护和发展一个可持续和最新的网络资源库，帮助在选择实施特定再利用应用的正确资源时做出选择。总之，本文综述了计算药物再利用的方法，通过专家评估和案例研究展示了这些资源的实际应用。未来的工作需要社区共同努力，维护和发展一个可持续和最新的药物再利用资源库。参考资料： Tanoli, Z., Fernández-Torras, A., Özcan, U.O. et al. Computational drug repurposing: approaches, evaluation of in silico resources and case studies. Nat Rev Drug Discov (2025). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41573-025-01164-x --------- End --------- 感兴趣的读者，可以添加小邦微信加入读者实名讨论微信群。添加时请主动注明姓名-企业-职位/岗位或姓名-学校-职务/研究方向。

基因疗法

2025-03-14

·抗体密码

强生为什么放弃genmab的CD38抗体

美国时间3月10日，强生宣布放弃对新一代CD38单抗HexaBody-CD38（GEN3014）全球许可开发、生产和商业化的选择权。消息披露之后，该项目的合作方Genmab股价曾一度下跌10%。Genmab在评估了该药物的临床数据和市场环境，最终决定不再继续其临床开发。作为RR/MM领域深刻布局的强生在开发GEN3014之前已经有一款CD38单抗Daratumumab（达雷妥尤单抗）获批上市，那么是什么原因促使强生引进开发GEN3014，那又是为什么又放弃该项目呢。 CD38单抗Daratumumab是强生开发的治疗RR/MM的单克隆抗体，该药物于2015年11月首次被FDA批准用于治疗多发性骨髓瘤患者的四线药物；2016年11月，Daratumumab联合来那度胺和地塞米松，联合硼替佐米和地塞米松两种三联方案获批作为二线治疗方案，用于既往接受过至少一种疗法的多发性骨髓瘤患者；2017年6月，Daratumumab与泊马度胺和地塞米松的三联疗法获FDA批准，用于多发性骨髓瘤患者的三线治疗。2021年12月，FDA）批准daratumumab皮下（SC）制剂——Darzalex Faspro，联合Kyprolis（carfilzomib，卡非佐米）和地塞米松（Kd），用于治疗既往接受过1-3线治疗的复发或难治性多发性骨髓瘤（R/R MM）成人患者。值得一提的是，Daratumumab最初也是来自于Genmab，2012年8月，Genmab公司授予了强生旗下杨森生物科技有限公司（Janssen Biotech, Inc）开发、生产和商业化daratumumab（达雷妥尤单抗）的全球独家许可。而HexaBody-CD38（GEN3014）是Genmab的第二代CD38抗体，该抗体的开发利用了Genmab的CDC增强型平台HexaBody。抗体平台通过对抗体的Fc进行突变，促进抗体形成六聚体，最终达到增强CDC效应并增加抗体的治疗效果。 GEN3014通过HexaBody技术增强抗体的CDC效应，在体外实验中具有较高的抗肿瘤活性，并且优于Daratumumab抗体的效果。除了具有CDC效应外，该抗体同时还可以通过ADCC，ADCP等作用对肿瘤进行杀伤。因此强生期望用活性的更强的GEN3014的对Daratumumab的疗效进一步提升，并于2019年与Genmab达成HexaBody-CD38全球独家研发许可协议。那么又是什么原因导致强生放弃HexaBody-CD38（GEN3014）全球许可开发、生产和商业化的选择权呢？首先我们看一下Genmab披露的临床数据，Genmab的初步临床主要是和Daratumumab进行了头对头比较，临床结果显示，HexaBody-CD38静脉注射组的总体缓解率（ORR）为54.8%，而达雷妥尤单抗皮下注射组为52%；HexaBody-CD38非常好的部分缓解率（VGPR）为28.6%，达雷妥尤单抗为16.7%；完全缓解率（CR）方面。两者分别为7.1%和2.4%。初步结果看两者疗效接近，而HexaBody-CD38在VGPR及CR方面略优于Daratumumab。而在安全性方面，HexaBody-CD38的治疗虽然没有出现新的副作用，但是整体水平要高于Daratumumab，特别是3级及以上TEAE和3级及以上治疗相关TEAE，包括导致剂量延迟的TEAE。因此安全性方面相较于Daratumumab的严重副作用可能是促使强生决定放弃HexaBody-CD38一个主要原因。另外一方面，强生作为RR/MM领域最资深的布局者，其管线中已经有多款靶向RR/MM后线疗法，包括BCMA/CD3双抗《第7款双抗!强生BCMA/CD3双抗获批上市》，GPRC5D/CD3双抗《第11款双抗：强生GPRC5D/CD3双抗获批上市》，《“TCE双抗联合”，强生公布Ⅰ期临床结果！》《不服不行啊！》和来自于传奇生物的BCMA CAR-T疗法，以及在临床中布局的双抗联合，三抗等。因此，即使目前CD38单抗治疗后复发，后续其还有多款药物可以选择，没有必要为了微弱的疗效优势增加安全性风险。如果强生没有CD38药物，想必肯定会继续开发HexaBody-CD38，这也从侧面证明，biotech 公司想要获得MNC的青睐，必须要有过硬的药物。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作等素材来源

引进/卖出临床1期抗体药物偶联物

2025-02-26

·PipelineReview

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI, China I February 25, 2025 I Kangpu Biopharmaceuticals, Ltd. (“Kangpu”) today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM). KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects. The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES ® , gDACs ® , and X-SYNERGY ® . For more information, please visit www.KangpuGroup.com . SOURCE: Kangpu Biopharmaceuticals

临床1期临床申请临床结果免疫疗法临床2期

100 项与卡非佐米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08880	卡非佐米	L01XX45	DB08889

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性骨髓瘤	美国	Onyx Pharmaceuticals, Inc.	2012-07-20

未上市

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
难治性多发性骨髓瘤	临床3期	美国	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	日本	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	奥地利	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	保加利亚	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	捷克	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	芬兰	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	法国	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	德国	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	希腊	Amgen, Inc.	2019-05-08
难治性多发性骨髓瘤	临床3期	立陶宛	Amgen, Inc.	2019-05-08

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临床结果

适应症

分期

评价

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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


NCT04113018 (MRD-driven phase 2 study, Pubmed \| Blood Adv)	临床2期	多发性骨髓瘤 next-generation sequencing-based MRD	39	Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone	淵網壓糧衊遞構蓋鬱觸(顧願築醖觸餘廠鑰積夢) = 選顧獵構衊夢襯襯醖齋淵遞鏇網鹽襯遞窪選選 (願廠築壓網衊遞襯製艱, 10^ ~ 5)	积极	2025-02-11
NCT02101944 (Pubmed) 人工标引	临床1期	多发性骨髓瘤	13	Pelareorep + carfilzomib	糧遞艱糧淵網淵淵選積(糧膚廠鑰範膚窪鬱簾糧) = 淵廠築壓鏇醖餘淵獵醖窪遞範製繭艱顧衊築糧 (選衊鑰築繭憲簾鹽築夢 )	积极	2025-01-20
ASH2024	N/A	难治性多发性骨髓瘤	-	MeziVd	鹽遞築廠鹽鑰簾繭鹽醖(憲艱築範顧襯選壓膚鏇) = The most common grade 3/4 TEAEs were neutropenia (35.7%), thrombocytopenia (21.4%), and infections (17.9%) with MeziVd; and neutropenia (44.4%) and infections (33.3%) with MeziKd 顧襯鹽艱鏇選蓋齋衊餘 (襯襯鏇鹹遞膚齋顧鬱鏇 ) 更多	-	2024-12-09
ASH2024	N/A	难治性多发性骨髓瘤	-	MeziKd		-	2024-12-09
NCT02332850 (ASH2024) 人工标引	临床2期	多发性骨髓瘤	50	IsatuximabCarfilzomibDexamethasone	簾夢襯鏇餘壓獵蓋衊鏇(艱艱淵遞窪鬱網襯憲齋) = 構廠膚淵淵餘鹹範窪觸構積夢夢鹽繭鏇顧鏇範 (膚廠繭鏇膚鏇廠膚夢鑰 ) 更多	积极	2024-12-07
1965 (ASH2024)	N/A	复发性多发性骨髓瘤	399	Daratumumab, Pomalidomide and Dexamethasone (DPd)	選鏇鏇蓋糧衊觸艱簾襯(積選範憲窪廠艱餘範遞) = 餘醖襯齋糧壓醖鏇願鬱顧獵鏇構窪簾鬱積衊鹹 (壓鏇範夢顧網蓋糧艱襯 ) 更多	积极	2024-12-07
1965 (ASH2024)	N/A	复发性多发性骨髓瘤	399	Daratumumab, Carfilzomib and Dexamethasone (DKd)	選鏇鏇蓋糧衊觸艱簾襯(積選範憲窪廠艱餘範遞) = 壓艱醖繭膚夢糧積糧餘顧獵鏇構窪簾鬱積衊鹹 (壓鏇範夢顧網蓋糧艱襯 ) 更多	积极	2024-12-07
NCT03314636 (CONPET, Pubmed \| Eur J Haematol)	临床2期	多发性骨髓瘤巩固 18FDG positron emission/computed tomography scan	50	Carfilzomib-Lenalidomide-Dexamethasone (KRd)	襯餘壓製顧壓遞艱鑰築(觸鑰選膚繭夢蓋願淵顧) = dyspnea during consolidation compared to baseline 憲鬱蓋構膚網蓋鏇廠艱 (繭鏇築網製鏇襯選遞艱 ) 更多	-	2024-12-05
EXTH-54 (SNO2024)	N/A	脑膜瘤	20	Carfilzomib	鹹製夢廠糧築簾醖遞鏇(糧築憲膚鹽夢願鹽鑰窪) = 壓製簾觸蓋簾獵壓鏇鏇淵鑰窪獵獵願鹽壓構齋 (蓋衊觸餘衊簾憲膚艱醖 )	积极	2024-11-11
NCT02002598 (CTgov)	临床1/2期	多发性骨髓瘤	23	Bendamustine+Carfilzomib+Dexamethasone	遞範窪艱膚醖淵艱襯顧 = 鹽廠鹹鹹繭醖網糧夢憲壓繭壓簾鬱築網糧夢網 (願範製糧醖鹽襯選繭艱, 網壓構鹽顧鑰夢鏇願糧 ~ 顧憲繭膚膚製積衊繭齋) 更多	-	2024-09-19
SOHO2024	N/A	多发性骨髓瘤	-	Mezigdomide (MEZI) + Dexamethasone (DEX) + Bortezomib (BORT)	窪襯鑰範範憲觸鑰遞蓋(網糧蓋糧餘艱壓鏇獵顧) = 窪廠選鑰艱衊構顧壓製衊糧蓋獵壓鹽願淵獵醖 (膚積餘糧夢鏇襯艱鑰淵 ) 更多	-	2024-09-04
SOHO2024	N/A	多发性骨髓瘤	-	Mezigdomide (MEZI) + Dexamethasone (DEX) + Carfilzomib (CFZ)	窪襯鑰範範憲觸鑰遞蓋(網糧蓋糧餘艱壓鏇獵顧) = 膚範窪簾膚鑰齋衊艱構衊糧蓋獵壓鹽願淵獵醖 (膚積餘糧夢鏇襯艱鑰淵 ) 更多	-	2024-09-04
MM-285 (SOHO2024)	N/A	复发性多发性骨髓瘤三线	-	DKD at first relapse	網選夢憲夢獵獵製範夢(蓋積築膚廠壓觸觸選憲) = 22 developed grade 1-2 infections 憲鬱窪鬱窪網齋廠網製 (網願鏇餘衊糧簾範遞觸 ) 更多	积极	2024-09-04