NL-OMON53904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) - StrateGIST 1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- IDRX, Inc.
- 入组人数
- 3
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 99（—）
入选标准
- •Eligible participants are adults who have metastatic and/or surgically
- •unresectable GIST. A full list of inclusion and exclusion criteria are found in
- •Section 7.1 and Section 7.2.
- •Key Inclusion Criteria:
- •1. >=18 years of age
- •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
- •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.
- •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.
排除标准
- •Key Exclusion Criteria:
- •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.
研究者
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