A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1]

This is the first clinical trial of IDRX-42. The study is designed to evaluate the safety, tolerability, PK, and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST.

开始日期2022-08-01

申办/合作机构

IDRx, Inc.初创企业

CTR20230641 / Not yet recruiting临床1期

一项在转移性和/或不可切除的胃肠道间质瘤 (GIST) 受试者中进行的 IDRX-42 首次人体 (FIH) 研究

I 期主要： · 确定转移性和/或手术不可切除的 GIST 受试者的 IDRX-42 最大耐受剂量 (MTD) 和/或 II 期临床试验推荐剂量和时间表 (RP2DS) 次要： · 评估 IDRX-42 的安全性和耐受性 · 描述 IDRX-42 的药代动力学 (PK) 概况特性 · 评估 IDRX-42 的初步抗肿瘤活性探索性： · 探索潜在的预测性和/或药效学标志物 · 评估 KIT、PDGFRA 和其他相关基因突变等位基因片段的变化及其与临床结局的相关性 Ib 期主要： · 进一步描述 IDRX-42 在转移性和/或手术不可切除的 GIST 受试者中的安全性和耐受性特性 · 评估 IDRX-42 在转移性和/或手术不可切除的 GIST 受试者中的抗肿瘤活性次要： · 进一步评估 IDRX-42 的初步抗肿瘤活性 · 描述 IDRX-42 的药代动力学概况特性探索性： · 探索潜在的预测性和/或药效学标志物 · 评估 KIT、PDGFRA 和其他相关基因突变等位基因片段的变化及其与临床结局的相关性

开始日期-

申办/合作机构

Aptuit (Verona) Srl

[+2]

100 项与 IDRX-42 相关的临床结果

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100 项与 IDRX-42 相关的转化医学

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100 项与 IDRX-42 相关的专利（医药）

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项与 IDRX-42 相关的文献（医药）

2023-08-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Antitumor Efficacy of the Novel KIT Inhibitor IDRX-42 (Formerly M4205) in Patient- and Cell Line-Derived Xenograft Models of Gastrointestinal Stromal Tumor (GIST).

Article

作者: Schöffski, Patrick ; Verreet, Jasper ; Wozniak, Agnieszka ; Esdar, Christina ; De Sutter, Luna ; Linde, Nina ; Sciot, Raf ; Drechsler, Christine ; Vanleeuw, Ulla ; De Cock, Lore

PURPOSE:

The majority of gastrointestinal stromal tumors (GIST) are driven by constitutively activated KIT/PDGFRA kinases and are susceptible to treatment with tyrosine kinase inhibitors. During treatment, most of these tumors will develop secondary mutations in KIT or PDGFRA inducing drug resistance, so there is an unmet need for novel therapies. We tested the efficacy of IDRX-42, a novel selective KIT inhibitor with high activity toward the most relevant KIT mutations, in 4 GIST xenograft models.

EXPERIMENTAL DESIGN:

NMRI nu/nu mice were transplanted with patient-derived GIST xenograft models UZLX-GIST9 (KIT:p.P577del;W557LfsX5;D820G), UZLX-GIST2B (KIT:p.A502_Y503dup), UZLX-GIST25 (KIT:p.K642E), and the cell line-derived model GIST882 (KIT:p.K642E). Mice were treated daily with vehicle (control), imatinib (100 mg/kg), sunitinib (20 mg/kg), avapritinib (5 mg/kg), or IDRX-42 (10 mg/kg, 25 mg/kg). Efficacy was assessed by tumor volume evolution, histopathology, grading of histologic response, and IHC. The Kruskal-Wallis and Wilcoxon matched-pairs tests were used for statistical analysis, with P < 0.05 considered as significant.

RESULTS:

IDRX-42 (25 mg/kg) caused tumor volume shrinkage in UZLX-GIST25, GIST882, and UZLX-GIST2B, with a relative decrease to 45.6%, 57.3%, and 35.1% on the last day as compared with baseline, and tumor growth delay (160.9%) compared with control in UZLX-GIST9. Compared with controls, IDRX-42 (25 mg/kg) induced a significant decrease in mitosis. In UZLX-GIST25 and GIST882 grade 2-4 histologic response with myxoid degeneration was observed in all IDRX-42 (25 mg/kg)-treated tumors.

CONCLUSIONS:

IDRX-42 showed significant antitumor activity in patient- and cell line-derived GIST xenograft models. The novel kinase inhibitor induced volumetric responses, decreased mitotic activity, and had antiproliferative effects. In models with KIT exon 13 mutation IDRX-42 induced characteristic myxoid degeneration.

2023-02-23·Journal of medicinal chemistry1区 · 医学

Identification of M4205─A Highly Selective Inhibitor of KIT Mutations for Treatment of Unresectable Metastatic or Recurrent Gastrointestinal Stromal Tumors

1区 · 医学

Article

作者: Linde, Nina ; Blum, Andreas ; Glaser, Nina ; Brandstetter, Susanne ; Dorsch, Dieter ; Ruff, Aaron ; Petersson, Carl ; Busch, Michael ; Sherbetjian, Eva ; Buchstaller, Hans-Peter ; Esdar, Christina ; Grädler, Ulrich ; Schieferstein, Hanno

The treatment of gastrointestinal stromal tumors (GISTs) driven by activating mutations in the KIT gene is a prime example of targeted therapy for treatment of cancer. The approval of the tyrosine kinase inhibitor imatinib has significantly improved patient survival, but emerging resistance under treatment and relapse is observed. Several additional KIT inhibitors have been approved; still, there is a high unmet need for KIT inhibitors with high selectivity and broad coverage of all clinically relevant KIT mutants. An imidazopyridine hit featuring excellent kinase selectivity was identified in a high-throughput screen (HTS) and optimized to the clinical candidate M4205 (IDRX-42). This molecule has a superior profile compared to approved drugs, suggesting a best-in-class potential for recurrent and metastatic GISTs driven by KIT mutations.

项与 IDRX-42 相关的新闻（医药）

2024-11-17

·药明康德

12个月患者总生存率超90%的抗癌联合疗法；治疗慢性HBV感染的表观遗传沉默剂进入临床…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. Cue Biopharma公司公布了其两款新型生物制品的积极临床数据，其中接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者12个月时的总生存率为91.3%。 2. 胸苷酸合成酶抑制剂NUC-3373联用pembrolizumab在一项临床研究中使1名尿路上皮膀胱癌患者的靶病灶缩小了100%。 3. 用于治疗慢性乙肝病毒（HBV）感染的表观遗传沉默剂TUNE-401在新西兰获批进入1b期临床试验。药明康德内容团队整理 CUE-101、CUE-102：公布1期临床试验的新数据 Cue Biopharma公司公布其CUE-101治疗头颈癌和CUE-102治疗WT1阳性癌症的1期临床试验的积极新数据。CUE-101是该公司开发的一款基于白细胞介素-2（IL-2）的T细胞诱导剂，旨在选择性调节和激活HPV阳性T细胞，以提高疗效，同时减少传统免疫疗法的副作用。CUE-102是一种由两个呈递WT1肽的人白细胞抗原（HLA）分子、四个亲和力减弱的IL-2分子和一个效应减弱的人免疫球蛋白G（IgG1）Fc结构域组成的新型生物制品，被开发作为单一疗法治疗WT1阳性复发/转移性癌症患者。截至2024年9月11日的数据，接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性R/M HNSCC患者的客观缓解率（ORR）为46%，疾病控制率（DCR）为75%，12个月时的总生存率为91.3%，中位总生存期（OS）为21.8个月。在历史研究KEYNOTE-048中，pembrolizumab单药治疗的ORR为19%，12个月时的总生存率为51%，中位OS为12.3个月。在本研究中，1例患者达到完全缓解（CR），10例患者达到部分缓解（PR），以及7例患者获得了超过12周的持久疾病稳定（SD）。接受该一线联合治疗的PD-L1低表达患者的ORR为50%。截至2024年10月29日的数据，接受CUE-102单药治疗的晚期胰腺癌患者的DCR为67%，其中包括肿瘤负荷减少40%的未确认的PR。有证据表明，WT1特异性CD8阳性T细胞受到了选择性刺激和扩增，而非特异性CD8阳性T细胞的总数没有明显增加。 NUC-3373：公布1b/2期联合治疗临床试验数据 NuCana公司公布了其正在进行的1b/2期模块化研究的初步数据，模块1研究评估了NUC-3373联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者的疗效，模块2研究评估了NUC-3373联用多西他赛治疗肺癌患者的疗效。NUC-3373是一种胸苷酸合成酶抑制剂，由核苷类似物5-氟尿嘧啶衍生而来，可导致DNA损伤。模块1包括12名患有各种实体瘤、已用尽所有其他治疗方案的患者，其中9例患者曾接受过PD-1/PD-L1抑制剂的治疗。接受NUC-3373联用pembrolizumab治疗后，患者实现了显著的肿瘤体积缩小，PFS得到延长。2名患者获得了确认的PR，4例患者达到SD。在疗效可评估人群中，ORR为22%，DCR为67%。其中，1例尿路上皮膀胱癌患者接受联合治疗后靶病灶缩小了100%（非靶病灶依然存在），1例BRAF突变转移性皮肤黑色素瘤患者的靶病灶缩小了81%。此外，NUC-3373联合pembrolizumab的耐受性普遍良好。模块2包括4名非小细胞肺癌（NSCLC）或胸膜间皮瘤患者，这些患者在既往含化疗方案中出现疾病进展或无法耐受。患者在接受NUC-3373联用多西他赛治疗后PFS得到延长，2例患者实现了长期的SD。 TUNE-401：在新西兰获批启动1b期临床试验 Tune Therapeutics公司宣布，该公司已获得新西兰药品和医疗器械安全局（Medsafe）的临床试验申请（CTA）批准，将推进其用于治疗慢性HBV感染的表观遗传沉默剂TUNE-401进入1b期临床试验。 TUNE-401是一款潜在"first-in-class"的表观遗传沉默剂，利用Tune Therapeutics的多功能、模块化TEMPO平台所开发。TUNE-401通过脂质纳米颗粒（LNP）将编码活性、HBV靶向的RNA直接递送至肝细胞。在这些细胞内，所递送的RNA被翻译为表观沉默蛋白，靶向整合入宿主细胞的乙肝病毒DNA（intDNA）和共价闭合环状DNA（cccDNA）。cccDNA是一种独特、游离的环状染色体（episomes），可作为病毒进行复制时的模板，是造成HBV患者多年持续感染的原因之一。临床医生认为，关闭这些cccDNA“病毒工厂”是实现HBV功能性治愈的必要前提。TUNE-401不涉及切割或编辑DNA，其导致产生的活性表观沉默蛋白通过添加甲基基团与DNA结合，以抑制或失活病毒基因，同时保持人类基因的完整性。根据新闻稿，TUNE-401是首个获批进入临床，用以治疗常见传染病的表观遗传疗法。 KVA12123：公布1/2期临床试验数据 Kineta公司公布了其正在进行的1/2期临床试验的最新进展，该试验评估了其新型在研VISTA阻断免疫疗法KVA12123单药或与PD-1抑制剂pembrolizumab联用在晚期实体瘤患者中的治疗效果。KVA12123是一种单克隆抗体疗法，需每周输注两次。通过将独特的表位与优化的IgG1 Fc区相结合，KVA12123单药在临床前模型中显示出强大的肿瘤生长抑制作用，且在临床试验中没有报告细胞因子释放综合征（CRS）。KVA12123已被证明能降低VISTA靶点的风险，并提供了一种新的方法来解决肿瘤微环境中的免疫抑制问题，其作用机制与以T细胞为重点的疗法不同且互补。截至2024年10月18日的数据，接受KVA12123单药治疗并至少进行了一次随访扫描的19例患者中，有13名实现了SD。在许多接受KVA12123单药治疗的患者中观察到持久的临床结果，其中1名此前已接受过六线治疗（包括免疫检查点抑制剂治疗）的NSCLC患者已保持SD状态60周。在接受KVA12123联合pembrolizumab治疗并至少进行了一次随访扫描的9例患者中，1例粘液表皮样癌患者获得了PR，靶病灶缩小了54%，非靶病灶获得了CR；1名免疫检查点抑制剂治疗后进展的肾细胞癌患者达到SD，靶病灶缩小了24%。安全性方面，KVA12123的耐受性良好，单药或与pembrolizumab联用在任何剂量水平上都未出现剂量限制性毒性（DLT）。 IDRX-42：公布1/1b期临床试验的新数据 IDRx公司公布了其用于治疗晚期胃肠道间质瘤（GIST）的在研口服小分子KIT酪氨酸激酶抑制剂IDRX-42的1/1b期临床试验数据。IDRX-42旨在选择性地靶向最常见的KIT突变形式，这些突变要么驱动肿瘤细胞的初始生长、增殖和生存，要么使肿瘤对现有疗法产生耐药性。截至2024年9月30日的数据，87例中位治疗线数为四线、疗效可评估患者的ORR为29%，包括1例CR和24例PR。接受IDRX-42作为二线治疗患者的ORR为53%（8/15），包括1例CR和7例PR，这些患者的中位PFS尚未达到。接受IDRX-42作为三线治疗的患者的中位PFS估计为12.9个月。既往未使用过ripretinib、接受IDRX-42作为≥四线治疗的患者在推荐的1b期剂量下，其中位PFS估计为11.0个月。此外，IDRX-42具有良好的安全性，在推荐的1b期剂量下，8%的患者减少了剂量，没有因治疗伴发不良事件而停药的情况。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。此次公布的结果显示，16例疗效可评估的患者中有9例（56%）达到SD，其中，1例结肠癌患者已保持SD超过6个月。最长的SD持续时间发生在一名乳腺癌患者中，该患者进入研究时病情发生进展，目前病情保持稳定，且已参与研究超过11个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未观察到严重的肝毒性。肝毒性是其他4-1BB靶向治疗的常见副作用，可导致患者停药。 ELI-002：公布1期临床试验的初步数据 Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002用于治疗接受标准局部治疗后仍有疾病复发风险的KRAS突变驱动实体瘤的1期临床试验的初步结果。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。初步数据表明，靶向KRAS突变体的T细胞反应持久且呈剂量依赖性，并诱导了针对患者特异性新抗原的反应。观察到无病生存期（DFS）与T细胞反应强度之间存在相关性。此外，ELI-002的1期安全性及耐受性特征依然良好，未观察到DLT或CRS。 GUBamy：公布1期临床试验数据 Gubra公司公布了长效胰淀素（amylin）类似物GUBamy在单剂量递增（SAD）1期临床试验中获得的积极结果。GUBamy耐受性良好，表现出良好的药代动力学特征，半衰期为11天，支持每周一次的给药方案。此外，单剂量的GUBamy剂量依赖性地降低体重，这一效果在试验期间（6周）内持续存在。在所有高剂量组（3.5-6.0 mg）中，受试者在6周试验期内的平均体重下降约3％，而安慰剂组的体重平均增长约1％。 ▲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] Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B. 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Retrieved November 15, 2024, from https://elicio.com/press_releases/elicio-therapeutics-presents-updated-translational-data-from-eli-002-phase-1-amplify-7p-study-at-the-society-for-immunotherapy-of-cancer-sitc-2024-annual-meeting/ [7] NuCana Announces Encouraging Initial Data from Phase 1b/2 Modular Study of NUC-3373 in Combination with Pembrolizumab or Docetaxel. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978192/0/en/NuCana-Announces-Encouraging-Initial-Data-from-Phase-1b-2-Modular-Study-of-NUC-3373-in-Combination-with-Pembrolizumab-or-Docetaxel.html [8] First-in-Class Bispecific Antibody, ALG.APV-527, Meets Important Trial Endpoints in Phase 1 Solid Tumor Trial. Retrieved November 15, 2024, from https://alligatorbioscience.se/en/mfn_news/first-in-class-bispecific-antibody-alg-apv-527-meets-important-trial-endpoints-in-phase-1-solid-tumor-trial/ [9] Immunic Announces Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/immunic-announces-publication-of-data-from-phase-11b-clinical-trial-of-imu-856-in-the-peer-reviewed-journal-the-lancet-gastroenterology--hepatology-302303813.html [10] Synthekine Announces Presentation of New Translational Data from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. Retrieved November 15, 2024, from https://www.synthekine.com/news/synthekine-announces-presentation-of-new-translational-data-from-phase-1a-1b-clinical-trial-of-%ce%b1-%ce%b2-biased-il-2-stk-012-at-the-society-for-immunotherapy-of-cancer-sitc-39th-annual-meeting/ [11] Infinitopes to Showcase Breakthroughs on Cancer Vaccine Development at SITC 2024: Insight into a double-blind, Phase I/IIa clinical trial. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/infinitopes-to-showcase-breakthroughs-on-cancer-vaccine-development-at-sitc-2024-insight-into-a-double-blind-phase-iiia-clinical-trial-302299015.html [12] Mural Oncology Presents Clinical and Preclinical Data Across its Pipeline at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). Retrieved November 15, 2024, from https://ir.muraloncology.com/news-releases/news-release-details/mural-oncology-presents-clinical-and-preclinical-data-across-its [13] Tectonic Therapeutic Announces Positive Phase 1a Results in AHA 2024 Presentation for TX45, a Long-acting, Fc-Relaxin Fusion Protein. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978120/0/en/Tectonic-Therapeutic-Announces-Positive-Phase-1a-Results-in-AHA-2024-Presentation-for-TX45-a-Long-acting-Fc-Relaxin-Fusion-Protein.html [14] CG Oncology Announces Nature Medicine Publication of Phase 1b Study Results Evaluating Cretostimogene Grenadenorepvec in Combination with Nivolumab in Muscle-Invasive Bladder Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978266/0/en/CG-Oncology-Announces-Nature-Medicine-Publication-of-Phase-1b-Study-Results-Evaluating-Cretostimogene-Grenadenorepvec-in-Combination-with-Nivolumab-in-Muscle-Invasive-Bladder-Cance.html [15] Next Generation Gene Therapeutics (NGGT) Announces Positive New Data on NGGT002 for the Treatment of Phenylketonuria (PKU). Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/next-generation-gene-therapeutics-nggt-announces-positive-new-data-on-nggt002-for-the-treatment-of-phenylketonuria-pku-302300911.html [16] Fate Therapeutics Highlights Cancer-selective, HER2-Targeting Profile of FT825 / ONO-8250 CAR T-cell Product Candidate for Treatment of Advanced Solid Tumors at 2024 SITC Annual Meeting. Retrieved November 15, 2024, from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-cancer-selective-her2-targeting [17] Neurogene Reports Positive Interim Efficacy Data from First Four Low-Dose Pediatric Participants in NGN-401 Gene Therapy Clinical Trial for Rett Syndrome. Retrieved November 15, 2024, from https://ir.neurogene.com/news-releases/news-release-details/neurogene-reports-positive-interim-efficacy-data-first-four-low [18] IND for ATA-200, a Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2C/R5 (LGMD2C/R5), cleared to proceed by FDA. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241112690214/en/IND-for-ATA-200-a-Gene-Therapy-for-the-Treatment-of-Limb-Girdle-Muscular-Dystrophy-Type-2CR5-LGMD2CR5-cleared-to-proceed-by-FDA [19] Nammi Therapeutics, Inc. Announces First Patient Dosed with QXL138AM in a Phase 1 Study Evaluating Advanced Solid Tumors and Multiple Myeloma. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/nammi-therapeutics-inc-announces-first-patient-dosed-with-qxl138am-in-a-phase-1-study-evaluating-advanced-solid-tumors-and-multiple-myeloma-302299498.html [20] Palleon Pharmaceuticals Presents Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241108273263/en/Palleon-Pharmaceuticals-Presents-Results-from-the-Phase-12-GLIMMER-01-Trial-of-E-602-in-Combination-with-Cemiplimab-in-Patients-with-Solid-Tumors-at-the-Society-for-Immunotherapy-of-Cancer-SITC-Annual-Meeting/ [21] Cerevance’s CVN293 Demonstrated Positive Phase 1 Results in Healthy Volunteers. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978299/0/en/Cerevance-s-CVN293-Demonstrated-Positive-Phase-1-Results-in-Healthy-Volunteers.html [22] Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089. Retrieved November 15, 2024, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-clinical-study-ck-2#:~:text=SOUTH%20SAN%20FRANCISCO%2C%20Calif.%2C%20Nov.%2011%2C%202024%20%28GLOBE,study%20of%20CK-4015089%20%28CK-089%29%20in%20healthy%20human%20participants. [23] EnteroBiotix Announces Positive Ph1b Clinical Results of EBX-102 in Liver Cirrhosis. Retrieved November 15, 2024, from https://www.enterobiotix.com/news/enterobiotix-positive-clinical-results-ebx-102-liver-cirrhosis [24] GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Gene Vector Therapy, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://genvivoinc.com/2024/11/08/genvivo-to-present-phase-1-trial-results-for-gen2-a-personalizing-gene-vector-therapy-at-the-2024-society-for-immunotherapy-of-cancer-sitc-annual-meeting/ [25] Sparian Biosciences Announces Results from the Phase 1 Clinical Trial of First in Class Novel Arylepoxamide Receptor (AEAr) Agonist Analgesic SBS-1000. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/12/2979419/0/en/Sparian-Biosciences-Announces-Results-from-the-Phase-1-Clinical-Trial-of-First-in-Class-Novel-Arylepoxamide-Receptor-AEAr-Agonist-Analgesic-SBS-1000.html [26] Spyre Therapeutics Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for SPY001, Its Novel Half-Life Extended anti-α4β7 Antibody for the Treatment of Inflammatory Bowel Disease, with a Half-Life of >90 Days Supporting the Potential for Both Q3M & Q6M Maintenance Dosing. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-results-from-phase-1-healthy-volunteer-trial-for-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-with-a-half-life-of-90-days-s-302302014.html [27] Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/14/2981017/0/en/Nuvectis-Pharma-Reports-Encouraging-NXP800-Interim-Data-Supporting-Ongoing-Enrollment-in-Phase-1b-Study-in-Patients-with-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html [28] Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis. Retrieved November 15, 2024, from https://enlivex.com/investors/news-releases/enlivex-announces-the-dosing-of-the-first-patient-in-a-phase-i-clinical-trial-evaluating-allocetra-in-patients-with-psoriatic-arthritis/#:~:text=Nes-Ziona%2C%20Israel%2C%20Nov.%2014%2C%202024%20%E2%80%94%20Enlivex%20Therapeutics,an%20affected%20joint%20in%20patients%20with%20psoriatic%20arthritis. 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2期临床结果免疫疗法临床1期

2024-11-14

·Business Wire

IDRx Announces Updated Phase 1 Data from Ongoing Phase 1/1b StrateGIST 1 Trial of IDRX-42 in Advanced Gastrointestinal Stromal Tumors (GIST) at CTOS 2024

PLYMOUTH, Mass.--( BUSINESS WIRE )--IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing precision therapeutics for the treatment of cancers with well-characterized biology and significant unmet medical need, today announced updated clinical data from StrateGIST 1, the company’s ongoing Phase 1/1b trial of IDRX-42 in patients with advanced gastrointestinal stromal tumors (GIST). These data continue to demonstrate promising anti-tumor activity of IDRX-42 in patients with advanced GIST and will be highlighted today in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting, being held November 13-16, in San Diego, CA. IDRX-42 is an investigational oral, small molecule, tyrosine kinase inhibitor (TKI) designed to selectively target the most prevalent KIT mutations that either drive the growth, proliferation, and survival of tumor cells (activating mutations in exons 9 and 11), or confer resistance to currently available therapies (resistance mutations in exons 13 and 17). “ In patients living with GIST, the therapeutic potential of KIT targeted TKIs has been limited by drug resistance caused by an inability to target the spectrum of the most prevalent KIT mutations, and poor tolerability,” said Suzanne George, M.D., Chief, Division of Sarcoma at the Dana-Farber Cancer Institute. “ These updated data from StrateGIST 1 are highly encouraging with respect to the clinical activity observed in later-line patients with a variety of KIT activating and resistance mutations. I am excited by the potential of IDRX-42, with its differentiated clinical profile demonstrated to date, to help meet this critical need for GIST patients.” “ We are particularly excited about the emerging durability data from StrateGIST 1. These data, together with the continued strengthening of response rate and tolerability data, underscore the potential for IDRX-42 to improve outcomes for GIST patients and support our plans to move IDRX-42 into late-phase development,” said Tim Clackson, Ph.D., Chief Executive Officer of IDRx. “ With FDA alignment now in place, we plan to conduct StrateGIST 3, a randomized, Phase 3 registrational trial which will evaluate the efficacy and safety of IDRX-42 as compared to sunitinib in second-line GIST patients. We remain steadfast in our commitment to transform the lives of patients with GIST, including in early-line settings, where the standards of care have remained unchanged for almost 20 years and a significant unmet need remains.” Presentation Highlights As of the data cut-off date of September 30, 2024, 89 patients have been treated with IDRX-42 in the Phase 1 portion of the ongoing StrateGIST 1 trial across dose cohorts ranging from 120 mg once daily (QD) to 1200 mg total daily dose (600 mg twice daily (BID)). All 89 patients had KIT -mutant GIST. 87 patients were evaluable for efficacy as of the data cut-off date. The two non-evaluable patients were recently enrolled and remain on treatment, awaiting their first post-baseline tumor assessment. While a maximum tolerated dose was not reached, dose escalation in the Phase 1 portion of the trial has been completed, and the Phase 1b dose confirmation portion of the trial has been initiated utilizing a dose of 300 mg in tablet formulation, which has comparable steady-state plasma exposure to a dose of 400 mg in capsule formulation. Patients were heavily pretreated overall, with a median of four prior lines of therapy. 17% (15/89) patients had received one prior line of therapy (IDRX-42 evaluated as second-line). 11% (10/89) patients had received two prior lines of therapy (IDRX-42 evaluated as third-line). 72% (64/89) patients had received three or more prior lines of therapy (IDRX-42 evaluated as ≥ fourth-line). 28% (25/89) received three or more prior lines of therapy that did not include ripretinib. As of the data cut-off date, 63% (56/89) of patients remained on study treatment, and the median duration of treatment was 6.6 months. The ORR by modified RECIST v1.1 in the total efficacy evaluable population was 29% (25/87) treated across all lines of therapy, including one complete response (CR) and 24 partial responses (PRs). Two of the PRs were awaiting confirmation at the time of the data cut. At the 400 mg capsule/300 mg tablet QD recommended Phase 1b dose (RP1bD), the ORR was 26% (10/38) in the total efficacy evaluable population. The ORR in second-line patients was 53% (8/15) including one CR and 7 PRs. At the RP1bD or below, the ORR was 50% (7/14) across second-line patients. In second-line patients (n=15), the 6-month PFS was 85%, and the median was not yet reached. The median PFS in third- or later-line patients both at the RP1bD (n=25) and across all doses (n=72) was 9.2 months. The median PFS in third-line patients overall (n=10) was 12.9 months. The median PFS in fourth- or later-line patients who had not previously received ripretinib (n=25) was 9.2 months, and at the RP1bD (n=10) was 11 months. IDRX-42 was generally well-tolerated and treatment-related adverse events (TRAEs) were mainly low grade at the RP1bD. The most frequently reported TRAEs (≥20%) were gastrointestinal symptoms (diarrhea, nausea, decreased appetite, vomiting, dysgeusia) and fatigue. An 8% dose reduction rate due to TRAEs was observed at RP1bD, with no TRAEs leading to dose discontinuation. The Phase 1b portion of StrateGIST 1 commenced enrollment in May 2024 and includes a first-, second-, and two later-line cohorts. The second- and two later-line cohorts are nearly fully enrolled. IDRx has aligned with the FDA on fundamental elements of the trial design, dose, and statistical analysis for StrateGIST 3, a global, randomized, Phase 3 registrational trial which will evaluate IDRX-42 as a second-line therapy in patients diagnosed with metastatic and/or unresectable GIST with disease progression on, or intolerance to, imatinib, the current first-line standard of care for GIST patients. Presentation Details Title: The Novel KIT inhibitor IDRX-42 Shows Promising Activity in Second- and Later-Line Gastrointestinal Stromal Tumors (GIST): Results from a Phase 1 Trial (StrateGIST 1) Presenter: Suzanne George, M.D. Abstract Number: P 10 Presentation Type: Oral Abstract Session Time: Thursday, November 14, 10:30 a.m. – 11:30 a.m. PST Location: Harbor Ballroom, Manchester Grand Hyatt, San Diego, CA About GIST Gastrointestinal stromal tumor (GIST) is the most common subtype of soft tissue sarcoma occurring in the gastrointestinal tract. Between 4,000 to 6,000 people are diagnosed with GIST in the United States each year. Approximately 80% of all GIST cases are driven by mutations in the KIT gene. An estimated 90% of patients who receive imatinib, the current standard of care for GIST, will experience disease progression related to the emergence of KIT resistance mutations. In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Despite the widespread availability of tyrosine kinase inhibitors approved for GIST, first-line and second-line standards of care have remained unchanged for almost 20 years and significant unmet need remains. About the StrateGIST 1 Study StrateGIST 1 is an ongoing, open-label, first-in-human Phase 1/1b study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IDRX-42 in patients with metastatic and/or surgically unresectable GIST after progression on imatinib and other approved drugs. The study is currently enrolling patients with documented pathogenic mutation in KIT or any platelet-derived growth factor receptor alpha (PDGFRA) mutation (other than PDGFRA exon 18) at sites in the U.S., United Kingdom, Belgium, the Netherlands, France, Germany, Italy, Spain, South Korea, and China. The Phase 1b portion commenced enrollment in May 2024 and includes four exploratory cohorts based on defined lines of prior tyrosine kinase inhibitor therapy, including first-, second-, third- and later-line therapies. About IDRX-42 IDRX-42 is an investigational oral, small molecule KIT tyrosine kinase inhibitor in clinical development as a monotherapy for the treatment of gastrointestinal stromal tumors (GIST). IDRX-42 is designed to selectively target the most prevalent forms of KIT mutations that either drive the initial growth, proliferation, and survival of tumor cells, or confer resistance to currently available therapies. In pre-clinical studies, IDRX-42 demonstrated superior anti-tumor activity as compared to imatinib, the current first-line of therapy, in tumors associated with both exon 9 and 11 KIT mutations. IDRX-42 was also shown in pre-clinical studies to have strong inhibition activity against the most prevalent KIT resistance mutations in exons 13 and 17, suggesting that IDRX-42 could prevent or substantially delay the emergence of such mutations. In xenograft models expressing secondary resistance mutations in KIT exon 13 or 17, IDRX-42 treatment resulted in potent and dose-dependent antitumor activity superior to the second-line standard of care agent, sunitinib. IDRX-42 is currently being evaluated in StrateGIST 1, a first-in-human Phase 1/1b trial. IDRX-42 has been granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration for the treatment of GIST after disease progression on imatinib. About IDRx IDRx is a clinical-stage biopharmaceutical company dedicated to developing and commercializing precision therapeutics for the treatment of cancers with well-characterized biology and significant unmet medical need. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong patients’ response to therapy. IDRx’s lead program is IDRX-42, which is designed to selectively target the most prevalent forms of KIT mutations and has the potential to improve outcomes for gastrointestinal stromal tumor (GIST) patients as a first- or second-line therapy, where the standards of care have remained unchanged for almost 20 years and significant unmet need remains. Founded in 2021, IDRx’s leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved medicines. To learn more, please visit www.idrx.com and follow us on LinkedIn .

临床结果临床1期快速通道临床3期孤儿药

2024-08-12

·医药观澜

10家创新药公司完成新一轮融资，包括2家中国公司

▎药明康德内容团队报道根据即刻药数数据库，上周（8月5日~8月11日），全球生物制药领域至少10家致力于创新药研发的公司宣布完成新一轮融资，其中包括2家来自中国的创新生物医药公司。这些获得融资的公司的技术和管线涉及多肽药物、免疫疗法、抗病毒疗法、基因编辑疗法、干细胞疗法等领域。公司：正序生物融资轮次：A+轮融资金额：超亿元人民币 8月8日，正序生物宣布完成超亿元人民币的A+轮融资，由上海国投孚腾资本领投，联新资本、博裕资本、礼来亚洲基金、万物资本、红杉中国等现有股东跟投。融资资金将用于进一步加速CS-101临床研究和商业化推进，并支持体内基因治疗管线的临床转化等。正序生物专注于开发新型基因编辑疗法，针对遗传疾病、代谢疾病、心血管疾病等疾病，已布局了多条管线。其中CS-101注射液是针对血红蛋白病开发的创新型基因编辑疗法，该产品针对β-地中海贫血症的1期临床试验正在推进。该产品于今年4月在中国获批临床。公司：IDRx 融资轮次：B轮融资金额：1.2亿美元 8月7日，致力开发癌症精准疗法的IDRx公司宣布完成1.2亿美元超额B轮融资。此次融资由RA Capital Management、Commodore Capital和Blackstone Multi-Asset Investing领投，其他新投资者包括Rock Springs Capital和一家总部位于美国的专注于医疗保健的基金。现有投资者包括Andreessen Horowitz（a16z）Bio+Health、Casdin Capital、Nextech Invest、Forge Life Science Partners、联合创始人Nick Lydon博士和战略合作伙伴德国默克（Merck KGaA）等也参与了融资。此轮融资的资金将用于支持IDRx公司主要候选产品IDRx-42的1/1b期胃肠道间质瘤（GIST）临床研究，以及资助该在研产品在二线GIST患者中第一项关键研究的启动。IDRx-42是一种强效、口服、高度选择性的KIT抑制剂，靶向KIT突变GIST患者的所有主要激活和耐药突变类别。早前，美国FDA曾授予IDRX-42快速通道资格，用于治疗伊马替尼治疗后疾病进展或不耐受后的GIST患者。公司：Red Queen Therapeutics 融资轮次：A轮融资金额：5500万美元 8月6日，专注于开发新型抗病毒药物的Red Queen Therapeutics宣布完成Apple Tree Partners（ATP）提供的5500万美元A轮融资，用于其新型抗病毒多肽药物的临床前开发。Red Queen Therapeutics由ATP和医学博士Loren Walensky共同创立，该公司基于一种新型脂肽平台技术开发抗病毒疗法，该技术可阻断病毒-细胞融合，也就是所有包膜病毒进入细胞的方式。该公司正在开发的抗病毒疗法不依赖于免疫系统激活，而是作用于病毒本身，以抑制病毒感染的进展并加速病毒清除。公司：Shinobi Therapeutics 融资轮次：A轮融资金额：5900万美元 8月6日，Shinobi Therapeutics宣布获得日本医疗研究开发机构（AMED）5900万美元的投资，用于支持公司针对GPC3+实体肿瘤的iPS-T细胞疗法项目的开发。此外，其他投资者Yosemite和Mitsubishi UFJ Capital也参与了该公司的投资，目前该公司A轮融资已达1.19亿美元。 Shinobi Therapeutics致力于开发一种新型免疫逃逸型iPS细胞疗法，这种干细胞疗法可以与患者的免疫系统形成协同作用，而不是对抗。该公司的开发策略是对iPSCs进行编辑，使其具高度免疫逃逸性，然后再使用其专有技术使iPSCs进行分化以创建CD8αβ iPS-T细胞。Shinobi目前已经建立多个在研管线，适应症涉及实体瘤、自身免疫性疾病和糖尿病等。公司：NeuroTherapia 融资轮次：B轮融资金额：1230万美元 8月6日，专注于开发神经退行性疾病疗法的NeuroTherapia宣布完成1230万美元B轮融资。B轮融资由Cleveland Clinic（克利夫兰诊所）领投，先前投资者Brain Trust Accelerator Fund II，Dolby Family Ventures和阿尔茨海默氏症药物发现基金会（ADDF）以及新投资者Foundation for a Better World and CRUINT均参与投资。该轮融资的资金将主要用于继续推进其CB2受体激动剂NTRX-07治疗阿尔茨海默病（AD）的临床开发。NTRX-07目前处于2期临床研究阶段。公开信息显示，该产品具有中枢神经系统活性，靶向小胶质细胞上的CB2受体，可显著降低炎症因子的表达，从而导致神经元存活和激活。神经炎症被认为在一系列神经系统疾病中起关键作用，如阿尔茨海默病、神经性疼痛、多发性硬化等。公司：仁远生物融资轮次：种子轮融资金额：数百万元近日业内传来消息，专注于血管修复干细胞治疗的仁远生物完成数百万元种子轮融资，投资方为普禾资本。公开资料显示，仁远生物专注于通过血管修复干细胞技术开发心脑血管疾病治疗产品。该公司采用血管修复干细胞技术，通过参与调节血管新生、损伤血管修复以及疏通血管，有望为心脑血管疾病治疗开辟新途径。仁远生物目前打造了4个在研管线产品，包括VCP01、VCP02、VCP03三款在研药物以及MV3D-01型3D血管芯片在研产品，其中三款在研药物计划于2025年申报IND。公司：Release Therapeutics 融资轮次：种子轮融资金额：330万瑞士法郎 8月6日消息，Release Therapeutics完成330万瑞士法郎的种子轮融资。该公司开发了一种细胞大胶囊技术（cell macroencapsulation technology ），旨在将强效治疗性蛋白输送到人类血脑屏障之外。该公司的技术将这种可植入的大胶囊装置与一种永生化成肌细胞系相结合，该细胞系能够产生多种蛋白质，长期输送到中枢神经系统。这种将生物技术和医疗技术相结合的创新，旨在不进行基因治疗的情况下治疗中枢神经系统的遗传性疾病。 Release Therapeutics的主要项目正在临床前开发，用于治疗异染性白质营养不良（MLD），这是一种罕见遗传性疾病，会导致髓磷脂的逐渐丧失，通常影响幼儿。此次融资是在该公司在异染性脑白质营养不良（MLD）动物模型中首次取得临床前结果之后完成。公司：Amlogenyx 融资轮次：种子轮融资金额：1400万美元近日业内消息，Amlogenyx完成了1400万美元的种子轮融资。此次由GordonMD®Global Investments LP和相关投资者以及Ultragenyx Pharmaceutical领投。该公司由Ultragenyx 分拆而来，正在研究和开发阿尔茨海默病和其他淀粉样蛋白疾病的新型基因疗法。Amlogenyx计划用这笔融资资金来推进其第一款蛋白酶候选产品，这款产品旨在有效分解和降解Aβ42。科学界普遍认为Aβ42是导致阿尔茨海默病发生的关键蛋白质。公司：Nammi Therapeutics 融资轮次：B轮融资金额：3000万美元 8月6日消息，Nammi Therapeutics获得了骨髓瘤投资基金（MIF）100万美元的投资，该投资是3000万美元B轮融资的一部分。这项投资是在该公司主导项目QXL138AM的第一项人体1期研究计划开始之前进行的，该研究针对的是局部晚期不可切除和/或转移性实体瘤和多发性骨髓瘤患者。 Nammi Therapeutics是一家免疫肿瘤学公司。其QXL138AM是一种掩蔽免疫细胞因子（MIC），由与靶向肿瘤细胞表面CD138蛋白的抗体融合的掩蔽干扰素α（IFNa）组成。临床前数据表明，QXL138AM在10多种肿瘤类型中包括多发性骨髓瘤中具有显著抗肿瘤疗效。基于这些，该产品已获得FDA授予多发性骨髓瘤的孤儿药资格。公司：MBX Biosciences 融资轮次：C轮融资金额：6350万美元 8月5日消息，专注于新型肽类药物研发的MBX Biosciences宣布了一项由Deep Track Capital领投的6350万美元的C轮融资，用于支持其正在进行的每周一次MBX-2109治疗甲状旁腺功能减退症的2期临床研究，以及加速推进早期研发管线。新投资者Driehaus Capital Management和T.Rowe Price Associates以及现有投资者Frazier Life Sciences、OrbiMed和Wellington Management等参投。 MBX Biosciences专注于发现和开发新型精确肽疗法，用于内分泌和代谢紊乱治疗。该公司的MBX 2109是一款甲状旁腺激素肽前体药物，已进入甲状旁腺功能减退症的2期临床试验，预计将于2025年三季度获得基线结果。另一款MBX 1416是一款用于减肥后低血糖的候选产品，正在进行1期研究。该公司还拥有肥胖和代谢性疾病的早期候选药物组合，其中长效GLP-1/GIP受体共激动剂前药MBX 4291正在推进IND申报。希望在投资市场的助力下，这些前沿技术和疗法可以早日造福病患。参考资料： [1]各公司官网和公开资料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。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。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。

基因疗法快速通道临床1期免疫疗法

100 项与 IDRX-42 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
胃肠道间质瘤	临床1期	美国	Aptuit (Verona) Srl	2022-08-03
胃肠道间质瘤	临床1期	美国	丘以思（上海）医药信息咨询有限公司	2022-08-03
胃肠道间质瘤	临床1期	中国	Aptuit (Verona) Srl	2022-08-03
胃肠道间质瘤	临床1期	中国	IDRx, Inc.初创企业	2022-08-03
胃肠道间质瘤	临床1期	中国	丘以思（上海）医药信息咨询有限公司	2022-08-03
胃肠道间质瘤	临床1期	比利时	Aptuit (Verona) Srl	2022-08-03
胃肠道间质瘤	临床1期	比利时	丘以思（上海）医药信息咨询有限公司	2022-08-03
胃肠道间质瘤	临床1期	法国	IDRx, Inc.初创企业	2022-08-03
胃肠道间质瘤	临床1期	法国	丘以思（上海）医药信息咨询有限公司	2022-08-03
胃肠道间质瘤	临床1期	法国	Aptuit (Verona) Srl	2022-08-03

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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


NCT05489237 (StrateGIST1 \| StrateGIST 1, BusinessWire) 人工标引	临床1期	胃肠道间质瘤 KIT Mutation	89	IDRX-42	鹽窪糧憲餘鬱廠構構壓(繭鹽鏇艱襯製製構鬱蓋) = 膚觸餘遞鏇壓醖糧築遞願簾築窪鑰獵餘製製齋 (醖築壓遞鑰廠鑰淵壓醖 ) 更多	积极	2024-11-14
NCT05489237 (StrateGIST1 \| StrateGIST 1, BusinessWire) 人工标引	临床1期	胃肠道间质瘤 KIT Mutation	89	IDRX-42 (second-line)	鹽窪糧憲餘鬱廠構構壓(繭鹽鏇艱襯製製構鬱蓋) = 製鹹獵壓鹽觸襯願襯遞願簾築窪鑰獵餘製製齋 (醖築壓遞鑰廠鑰淵壓醖 ) 更多	积极	2024-11-14
StrateGIST 1 (Biospace) 人工标引	临床1期	胃肠道间质瘤 KIT Mutation	73	IDRX-42	淵艱壓鬱鹹遞積觸糧鹽(糧齋鹽鏇鏇壓廠鬱壓築) = 鹹夢鹹壓餘淵壓鹹糧糧遞壓鹽壓壓醖鹽廠鑰構 (窪膚範醖餘艱鑰鏇獵廠 ) 更多	积极	2024-07-03
NCT05489237 (StrateGIST 1, ASCO2024)	临床1期	转移性胃肠道间质瘤	42	IDRX-42 120 mg QD	窪積艱糧衊簾蓋構廠鏇(獵範襯鏇醖窪餘構範積) = 網艱構構顧廠鏇範觸繭構壓壓衊鹹糧築膚鑰廠 (壓選顧構簾衊鏇醖網鹹 ) 更多	积极	2024-05-24
NCT05489237 (StrateGIST 1, ASCO2024)	临床1期	转移性胃肠道间质瘤	42	IDRX-42 240 mg QD	窪積艱糧衊簾蓋構廠鏇(獵範襯鏇醖窪餘構範積) = 窪網構齋鏇衊鑰顧觸鬱構壓壓衊鹹糧築膚鑰廠 (壓選顧構簾衊鏇醖網鹹 ) 更多	积极	2024-05-24
NCT05489237 (StrateGIST1, Biospace) 人工标引	临床1期	胃肠道间质瘤 KIT Mutation	33	IDRX-42	膚願網鏇艱網選衊衊鏇(艱膚構廠願膚鹹構憲顧) = NR 鹹遞築艱簾襯鹹簾繭蓋 (齋醖簾糧簾醖餘醖憲膚 ) 更多	积极	2023-11-02