OncoMatch/Clinical Trials/NCT05489237

First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors

Is NCT05489237 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies IDRX-42 for gastrointestinal neoplasms.

Phase 1RecruitingIDRx Inc. - A GSK CompanyNCT05489237Data as of May 2026

Treatment: IDRX-42 — 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.

Check if I qualify

Extracted eligibility criteria

Cancer type

Gastrointestinal Stromal Tumor

Tumor Agnostic

Biomarker criteria

Required: KIT pathogenic mutation

Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations

Required: PDGFRA mutation (excluding exon 18)

any PDGFRA mutation other than exon 18 mutations

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: imatinib (imatinib)

Documented progression on imatinib

Cannot have received: NB003 (NB003)

Exception: Cohort 4 of Phase 1b

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)

Cannot have received: THE-630 (THE-630)

Exception: Cohort 4 of Phase 1b

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)

Cannot have received: bezuclastinib plus sunitinib combination (bezuclastinib, sunitinib)

Exception: Cohort 4 of Phase 1b

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)

Lab requirements

Cardiac function

no significant, uncontrolled, or active cardiovascular disease

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

GSK Investigational Site · Miami, Florida
GSK Investigational Site · Boston, Massachusetts
GSK Investigational Site · St Louis, Missouri
GSK Investigational Site · New York, New York
GSK Investigational Site · Portland, Oregon

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify