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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: Recruiting Phase 1 study of Metastatic Cancer and Gastrointestinal Diseases, sponsored by IDRx Inc. - A GSK Company.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 278 participants
Start Date 2022-08-03
Est. Completion 2027-11-03
Phase Phase 1
IDRx Inc. - A GSK Company

1 total trials

What NCT05489237 shows while recruiting

NCT05489237 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 441-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (37% lower).

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 names 20 study sites across 8 states, led by 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.

Similar trials for Metastatic Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05489237's enrollment target sits among peer trials

278 18th of 109 higher than 92 of 109 other Metastatic Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05489237, the US trial registry maintained by the National Library of Medicine. NCT05489237 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.