RecruitingPhase 1

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

United States, Belgium, China278 participantsStarted 2022-08-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. At least one measurable lesion by mRECIST v1.1 for participants with GIST
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)

Timeframe: 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)

Timeframe: Approximately 18 months from first participant enrolled

Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42

Timeframe: Approximately 18 months from first participant enrolled

Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysis

Timeframe: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)

Phase 1b-Number of participants with TEAEs and with laboratory test results

Timeframe: Approximately 18 months

Phase 1b - Objective Response Rate (ORR) mRESIST v1.1

Timeframe: Approximately 18 months

Trial details

NCT IDNCT05489237

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-10

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Gastrointestinal Neoplasms trials