Last updated: 10/17/2025 15:40:23

A Study of IDRX-42 (GSK6042981) versus (vs) sunitinib in Participants with Gastrointestinal Stromal Tumors after imatinib Therapy

GSK study ID
300383
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2025-522229-37-00
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Progression-Free Survival (PFS)

Timeframe: Up to approximately 130 weeks

Secondary outcomes:

Overall Survival (OS)

Timeframe: Up to approximately 261 weeks

Progression-Free Survival (PFS)

Timeframe: Up to approximately 261 weeks

Confirmed Overall Objective Response Rate (ORR)

Timeframe: Up to approximately 261 weeks

Time to Response (TTR)

Timeframe: Up to approximately 261 weeks

Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)

Timeframe: Up to approximately 261 weeks

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)

Timeframe: Baseline (Day 1) and up to approximately 261 weeks

Time To Confirmed Deterioration (TTCD)

Timeframe: Up to approximately 261 weeks

Plasma concentrations of IDRX-42 (GSK6042981)

Timeframe: Up to approximately 261 weeks

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Up to approximately 261 weeks

Number of Participants with TEAEs and SAEs by severity

Timeframe: Up to approximately 261 weeks

Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity

Timeframe: Up to approximately 261 weeks

Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Timeframe: Up to approximately 261 weeks

Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)

Timeframe: Up to approximately 261 weeks

Interventions:
  • Drug: IDRX-42
  • Drug: Sunitinib
    • Enrollment:
    450
    Primary completion date:
    2028-26-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Gastrointestinal Neoplasms
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2025 to October 2030
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
    • Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
    • Known untreated or active central nervous system metastases.
    • Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
    Inclusion and exclusion criteria
    Inclusion criteria:

      •Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. •Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. •Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

    Exclusion criteria:

      •Known untreated or active central nervous system metastases. •Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded. •Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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