A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Conditions

• Gastrointestinal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IDRX-42 — DRUG
  IDRX-42 will be administered.
• Sunitinib — DRUG
  Sunitinib will be administered.

Study Details

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

Key Dates

First listed

Oct 21, 2025

Start date

Dec 3, 2025

Status verified

Jun 2026

Primary completion

May 30, 2028

Completion

Nov 29, 2030

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IDRX-42 (GSK6042981)
• Active Comparator: Sunitinib

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 130 weeks ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (36)

Find similar trials in Phoenix, AZ

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