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RECRUITING Phase 1

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

NCT05489237 · View on ClinicalTrials.gov ↗

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

Sponsor

IDRx Inc. - A GSK Company

32 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IDRx Inc. - A GSK Company, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05489237 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05489237?

The interventions under investigation include: IDRX-42 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05489237?

This trial is sponsored by IDRx Inc. - A GSK Company, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial