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 (Jun 2026). This Phase 1 trial studies IDRX-42 for gastrointestinal neoplasms.
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 qualifyExtracted eligibility criteria
Treatments studied
Other
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 →Frequently asked questions
Is NCT05489237 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior NB003, THE-630, bezuclastinib plus sunitinib combination disqualifies patients from enrollment.
Does this trial require KIT?
Yes, KIT pathogenic mutation is a required biomarker for enrollment.
Does this trial require PDGFRA?
Yes, PDGFRA mutation (excluding exon 18) is a required biomarker for enrollment.
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