IDRX-42

DRUG2 trials

Sponsors

IDRX, Inc., a wholly owned subsidiary of GSK, LLC, GlaxoSmithKline

Conditions

Digestive System DiseaseGastrointestinal DiseasesGastrointestinal NeoplasmsGastrointestinal Stromal Tumor (GIST)Metastatic Cancer

Phase 1

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

Active, not recruitingNCT05489237

IDRX, Inc., a wholly owned subsidiary of GSK, LLCDigestive System Disease, Gastrointestinal Diseases, Gastrointestinal Neoplasms +2

Start: 2022-08-03End: 2027-03-26Updated: 2026-07-02

Phase 3

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

RecruitingNCT07218926

GlaxoSmithKlineGastrointestinal Neoplasms

Start: 2025-12-03End: 2030-11-29Target: 450Updated: 2026-09-08

Related Papers

StrateGIST 3: A randomized, phase 3 study of velzatinib (IDRX-42) versus sunitinib in patients with advanced gastrointestinal stromal tumors after imatinib therapy.

Journal of Clinical Oncology2026-05-28

Efficacy of velzatinib (IDRX-42) in patients with advanced/metastatic GIST by line of therapy and circulating tumor DNA response in the phase 1/1b StrateGIST 1 trial.

Journal of Clinical Oncology2026-05-27

Velzatinib (IDRX-42) as 1L or 2L therapy for advanced gastrointestinal stromal tumors (GISTs) by <i>KIT</i> mutation status: A subset analysis of the phase 1/1b StrateGIST 1 study.

Journal of Clinical Oncology2026-05-27

StrateGIST 1: A first-in-human (FIH), phase 1 study of IDRX-42 in patients with metastatic gastrointestinal stromal tumors resistant to prior treatment with tyrosine kinase inhibitors (TKIs).

Journal of Clinical Oncology2024-06-015 citations

Selected Articles from This Issue

Clinical Cancer Research2023-08-01

Phase 1/1b first-in-human study of IDRX-42, a novel oral tyrosine kinase inhibitor (TKI), in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GISTs).

Journal of Clinical Oncology2023-01-243 citations