cancer gastrointestinal stromal tumors
Conditions
Interventions
IDRX-42 will be administered orally daily in continuous 28-day cycles in both
Phase 1 and Phase 1b of this study.
Sponsors
IDRX, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 =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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b (Exploratory Cohorts) Primary: Safety: • Further characterize the safety and tolerability of IDRX-42 in participants with metastatic and/or surgically unresectable GIST Efficacy: • Evaluate the antitumor activity of IDRX-42 in participants with metastatic and/or surgically unresectable GIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • Further evaluate preliminary antitumor activity of IDRX-42 in participants with metastatic and/or surgically unresectable GIST • Characterize the PK profile of IDRX-42 in participants with metastatic and/or surgically unresectable GIST | — |
Countries
Netherlands
Outcome results
None listed