First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointesti… (NCT05489237) | Clinical Trial Compass
RecruitingPhase 1
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
United States278 participantsStarted 2022-08-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 one measurable lesion by mRECIST v1.1 for participants with GIST
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0 criteria, or have resolved to baseline, at the time of first dose of study drug.
✓. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
Exclusion criteria
✕. Any prior exposure to the following investigational agents NB003 or THE-630 or bezuclastinib plus sunitinib combination (except for participants treated in Cohort 4 of Phase 1b).
✕. GIST with no documented mutation in both KIT and PDGFRA genes.
✕. 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.
What they're measuring
1
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Timeframe: When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators
2
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Timeframe: Approximately 18 months from first participant enrolled
3
Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42
Timeframe: Approximately 18 months from first participant enrolled