jRCT2051240255招募中不适用
A first-in-human (FIH) study of IDRX-42 in participants with metastatic and/or unresectable gastrointestinal stromal tumors (GIST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- IDRX, Inc.
- 入组人数
- 12
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female participants >- 18 years of age
- •Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST.
- •Documented progression on imatinib (Phase 1)
- •Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations determined through local testing.
- •At least 1 measurable lesion by mRECIST v1.1 for participants with GIST.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Resolution of any toxicities from prior treatment(s) to Grade <- 1 by NCI CTCAE v5.0, or have resolved to baseline, at the time of first dose of study drug.
- •Able and willing to commit to study assessments and visit schedule.
- •Additional for Phase 1b Exploratory Cohorts
- •Cohort 1: progressed on imatinib only (second line therapy) and refused or are ineligible for other SOC therapies
- •Cohort 2: progressed on both imatinib and sunitinib (third-line therapy), or progressed on imatinib, sunitinib, and regorafenib (fourth-line therapy) or progressed on imatinib, sunitinib, regorafenib, and pimitespib (fifth-line or greater therapy)
- •Cohort 3: treatment naive (first line therapy) and refused or are ineligible for other SOC therapies
- •Cohort 4: met the same criteria as Cohort 2 (third line or greater) and have also had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination
排除标准
- •Any prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination (except for participants treated in Cohort 4 of Phase 1b).
- •GIST that is both KIT and PDGFRA wild-type.
- •Primary brain malignancy or known untreated or active central nervous system metastases.
- •Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics.
- •Has significant, uncontrolled, or active cardiovascular disease.
结局指标
主要结局
Safety
- Nature, incidence, and severity of TEAEs and change from baseline in laboratory results
Efficacy
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 modified for participants with GIST (mRECIST v1.1, (Demetri 2013)) per Investigator assessment
次要结局
- Duration of response (DOR)
- progression-free survival (PFS)
- Clinical benefit rate (CBR)
- Time to response (TTR)
研究者
相似试验
尚未招募
不适用
A first-in-human (FIH) study of IDRX-42 in participants with metastatic and/or unresectable gastrointestinal stromal tumors (GIST)cancerNL-OMON53904IDRX, Inc.3
招募中
1 期
A FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST)CTIS2024-514930-19-00Idrx Inc.234
进行中（未招募）
1 期
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal TumorsGastrointestinal Stromal Tumor (GIST)Gastrointestinal DiseasesMetastatic CancerNCT05489237IDRX, Inc., a wholly owned subsidiary of GSK, LLC276
进行中（未招募）
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CTR2023064130
招募中
不适用
A First-in-Human study of PRD001 in healthy participants, assessment of safety, tolerability and pharmacokinetics of single/multiple dosesjRCT2071250016PRD Therapeutics Inc.86