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

April 28, 2026 updated by: IDRX, Inc., a wholly owned subsidiary of GSK, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

278

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Schoffski
  • China
      • Beijing, China, 100142
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lin Shen
        • Contact:
        • Contact:
      • Guangzhou, China
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yanhong Deng
        • Contact:
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kai-Xiong Tao
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine Italiano
      • Lyon, France
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Yves Blay
        • Contact:
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florence Duffaud
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • axel LE CESNE
  • Germany
      • Berlin, Germany
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Reichardt
      • Essen, Germany, 45122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Bauer
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Rosa Fumagalli
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saori Mishima
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hidekazu Hirano
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Neeltje Steeghs
        • Contact:
        • Contact:
      • Rotterdam, Netherlands, 3075 EA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maja De Jonge
  • South Korea
      • Seongnam-si Gyeonggi-do, South Korea, 463-707
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keun-Wook Lee
      • Seoul, South Korea, 5505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min-Hee Ryu
      • Seoul, South Korea, 6351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jungyong Hong
      • Seoul, South Korea, 120-752
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Minkyu Jung
      • Seoul, South Korea, 3080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Do-youn Oh
  • Spain
      • Barcelona, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Serrano-Garcia
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Daniel Stark
        • Contact:
        • Contact:
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Robin Jones
        • Contact:
        • Contact:
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan Trent
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Viveiros
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Suzanne George
        • Contact:
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mia Weiss
        • Contact:
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ciara Kelly
        • Contact:
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Heinrich
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Margaret Von Mehren
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Neeta Somaiah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Phase 1

  1. Male or female participants ≥18 years of age
  2. Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST
  3. Documented progression on imatinib (Phase 1)
  4. Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations, determined through local testing
  5. At least one measurable lesion by mRECIST v1.1 for participants with GIST
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0 criteria, or have resolved to baseline, at the time of first dose of study drug.
  8. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.

Additional for Phase 1b Exploratory Cohorts

  1. For Cohort 1, progressed on imatinib only (second line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
  2. For Cohort 2, progressed on both imatinib and sunitinib (third line therapy) or progressed on imatinib, sunitinib, and an additional agent (i.e., regorafenib or ripretinib) (fourth line therapy) or progressed on imatinib, sunitinib, regorafenib, and ripretininb (fifth line or greater therapy)
  3. For Cohort 3 [US, UK, China, and Japan only], treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
  4. For Cohort 4, met the same criteria as Cohort 2 (third line or greater) and have also had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.

Exclusion Criteria:

  1. 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).
  2. GIST with no documented mutation in both KIT and PDGFRA genes.
  3. Primary brain malignancy or known untreated or active central nervous system metastases.
  4. Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics.
  5. Has significant, uncontrolled, or active cardiovascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation (Phase I)
Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST.
Drug: IDRX-42
Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.
Experimental: (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy
Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies.
Drug: IDRX-42
Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.
Experimental: (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy
Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy).
Drug: IDRX-42
Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.
Experimental: (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve
Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
Drug: IDRX-42
Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.
Experimental: (Phase 1b): Cohort 4
Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.
Drug: IDRX-42
Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1b - Objective Response Rate (ORR) mRESIST v1.1
Time Frame: Approximately 18 months
Approximately 18 months
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Time Frame: When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators
When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Time Frame: Approximately 18 months from first participant enrolled
Approximately 18 months from first participant enrolled
Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42
Time Frame: Approximately 18 months from first participant enrolled
Approximately 18 months from first participant enrolled
Phase 1b-Number of participants with TEAEs and with laboratory test results
Time Frame: Approximately 18 months
Approximately 18 months
Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysis
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1b - C-QTcF sub-study: QTcF - concentration response analysis
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 1 (Dose Escalation)- Number of participants with non-DLT TEAEs and with laboratory test results
Time Frame: 6 months
6 months
Phase 1 (Dose Escalation) - ORR per mRECIST v1.1
Time Frame: 6 months
6 months
Phase 1 (Dose Escalation) - Cmax; Maximum Observed Concentration of IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1 (Dose Escalation) - Tmax; Time of First Occurrence of Maximum Plasma Concentration (Cmax) of IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1 (Dose Escalation) - AUC 0-24; Area Under the Concentration-time Curve from Time Zero to 24 hours for IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1 (Dose Escalation) - Duration of response (DOR) per mRECIST v1.1
Time Frame: 6 months
6 months
Phase 1 (Dose Escalation) - Time to response (TTR) per mRECIST v1.1
Time Frame: 6 months
6 months
Phase 1 (Dose Escalation) - Progression-free survival (PFS), per mRECIST v1.1
Time Frame: 6 months
6 months
Phase 1b- Duration of response (DOR) per mRECIST v1.1
Time Frame: 18 months
18 months
Phase 1b - PFS per mRECIST v1.1
Time Frame: 18 months
18 months
Phase 1b - Clinical benefit rate (CBR) per mRECIST v1.1
Time Frame: 18 months
18 months
Phase 1b - TTR per mRECIST v1.1
Time Frame: 18 months
18 months
Phase 1b - Cmax; Maximum Observed Concentration of IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1b - Tmax; Time of First Occurrence of Maximum Plasma Concentration (Cmax) of IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1b - AUC 0-24; Area Under the Concentration-time Curve from Time Zero to 24 hours for IDRX-42
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1b - Overall survival
Time Frame: 18 months
18 months
Phase 1 (Dose Escalation) - C-QTcF sub-study: QTcF, heart rate, PR, QRS interval at baseline, post baseline and change from baseline.
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
Phase 1b C-QTc sub-study: QTcF, heart rate, PR, QRS interval at baseline, post baseline and change from baseline.
Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

March 10, 2027

Study Completion (Estimated)

June 28, 2028

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300382
  • IDRX-42-001 (Other Identifier: IDRx Inc. - A GSK Company)
  • 2024-514930-19-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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