NCT05489237

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

A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1]

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: IDRX, Inc., a wholly owned subsidiary of GSK, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. The study consists of 2 parts. Phase 1 comprises dose escalation to assess clinical and pharmacologic profile and safety/tolerability after failure of at least prior imatinib and support choice of the recommended phase 1b dose(s) and schedule(s) (RP1bDs)). Phase 1b expansion will enroll separate cohorts of participants defined by numbers of lines of prior GIST therapy at the selected RP1bD(s) to assess the preliminary antitumor effect of IDRX-42 and further characterize the safety profile of IDRX-42 at the RP1bD(s). In addition, a Concentration-QTc (C-QTc) substudy will be conducted in a subset of participants enrolled at selected sites in the study to characterize the effects of IDRX-42 on QTc and other ECG parameters in GIST patients.

Conditions

• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor (GIST)
• Digestive System Disease
• Gastrointestinal Diseases
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	IDRX-42	Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.

Timeline

• Start date: 2022-08-03
• Primary completion: 2027-11-03
• Completion: 2027-11-03
• First posted: 2022-08-05
• Last updated: 2025-11-17

Locations

30 sites across 11 countries: United States, Belgium, China, France, Germany, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study