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

NCT05489237 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

IDRX-42

Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2027-03-10
Completion
2028-06-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489237 on ClinicalTrials.gov