CTIS2024-514930-19-00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) - IDRX-42-001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Idrx Inc.
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. =18 years of age, unless country specific standards require a different age for minors (e.g. > 19 years of age in Korea)., 2. Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST., 3. Documented progression on imatinib (Phase 1)., 4. Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations, determined through local testing., 5. At least one measurable lesion by mRECIST v1.1 for participants with GIST (Demetri 2013)., 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., 7. 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. Note: unresolved prior treatment-related Grade 2 alopecia, Grade =2 peripheral neuropathy, and Grade =2 hypothyroidism on a stable dose of thyroid hormone replacement therapy are allowed if deemed irreversible., 8. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions., 9. Additional Inclusion Criteria for Phase 1b Exploratory Cohorts: (1)For Cohort 1, progressed on imatinib only (second line therapy) and refused or are ineligible for other SOCs. (2)For Cohort 2, progressed on both imatinib and sunitinib (third line therapy) or progressed on imatinib, sunitinib, and an additional agent (i.e., regorafenib or ripretinib) (fourth line therapy), or progressed on imatinib, sunitinib, regorafenib, and ripretinib (fifth line or greater therapy). (3)For Cohort 3 (applicable in US, UK, China, and South Korea only), treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. (4)For 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. Please refer to the study protocol for a complete list of inclusion criteria.
排除标准
- •1. 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)., 2. GIST that is both KIT and PDGFRA wild-type., 3. Primary brain malignancy or known untreated or active central nervous system metastases., 4. Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics., 5. Has significant, uncontrolled, or active cardiovascular disease. Please refer to the study protocol for a complete list of exclusion criteria.
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