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NCT05489237 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
A Phase 1 study of Metastatic Cancer and Gastrointestinal Diseases, sponsored by IDRx Inc. - A GSK Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 278
- Enrollment target
- 20
- Study locations
NCT05489237 is a Phase 1 study of Metastatic Cancer and Gastrointestinal Diseases that is actively recruiting participants, run by IDRx Inc. - A GSK Company. The registered enrollment target is 278 participants, below the 441-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT05489237, a Phase 1 study of Metastatic Cancer and Gastrointestinal Diseases, is actively recruiting participants, sponsored by IDRx Inc. - A GSK Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 278 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG IDRX-42
Study Locations (20)
Other
- GSK Investigational Site - Leuven
- GSK Investigational Site - Beijing
- GSK Investigational Site - Guangzhou
- GSK Investigational Site - Wuhan
- GSK Investigational Site - Bordeaux
- GSK Investigational Site - Lyon
- GSK Investigational Site - Marseille
- GSK Investigational Site - Villejuif
- GSK Investigational Site - Berlin
- GSK Investigational Site - Essen
- GSK Investigational Site - Milan
- GSK Investigational Site - Chiba
- GSK Investigational Site - Tokyo
Florida
- GSK Investigational Site - Miami
Massachusetts
- GSK Investigational Site - Boston
Missouri
- GSK Investigational Site - St Louis
New York
- GSK Investigational Site - New York
Oregon
- GSK Investigational Site - Portland
Pennsylvania
- GSK Investigational Site - Philadelphia
Texas
- GSK Investigational Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2027-11-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05489237
The ClinicalTrials.gov registry entry for NCT05489237 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 441-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (37% lower). The listed sponsor is IDRx Inc. - A GSK Company, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Metastatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which IDRX-42 is the first listed.
NCT05489237 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05489237 about?
NCT05489237 is a clinical study titled "First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors". 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.
What is the current status of trial NCT05489237?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 278 participants. The study started on 2022-08-03. Estimated completion is 2027-11-03.
What conditions does trial NCT05489237 study?
This clinical trial studies the following conditions: Metastatic Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumor (GIST), Digestive System Disease.
What interventions are being tested in trial NCT05489237?
The interventions under investigation include: IDRX-42 (DRUG).
Who is sponsoring clinical trial NCT05489237?
This trial is sponsored by IDRx Inc. - A GSK Company, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05489237 being conducted?
This trial has 20 study locations across Florida, Massachusetts, Missouri, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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