A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST1]

A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST1]

Gastrointestinal Stromal Tumor

Recruiting

1

Start Date 08/01/2022

Age of Trial (yrs) 1.7

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT/PDGFRA

Specifically GIST and only GIST

IDRX-42-001 StrateGIST1

IDRx, Inc.

IDRX Clinical Operations 339-234-7028 clinicaltrials@idrx.com

Oral

Detailed Description:
This is a Phase 1/1b open-label, first-in-human FIH study of IDRX-42, an orally administered small molecule tyrosine kinase inhibitor. Eligible participants will have metastatic and/or surgically unresectable GIST, after failure of at least imatinib due to progression of GIST. The study consists of 2 parts. Phase 1 comprises dose escalation to assess clinical and pharmacologic profile, safety/tolerability, and support choice of the recommended phase 2 dose and schedule (RP2DS). Phase 1b expansion will enroll separate cohorts of participants defined by numbers of lines of prior GIST therapy at the selected RP2DS to assess the preliminary antitumor effect of IDRX-42 and further characterize the safety profile of IDRX-42 at the RP2DS.

Inclusion Criteria:

Phase 1

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

Exclusion Criteria:

Any prior exposure to the following investigational agents NB003 or THE-630 or bezuclastinib plus sunitinib combination.
GIST with no documented mutation in both KIT and PDGFRA genes.