Last updated: 12/02/2025 13:20:22

A study of GSK5764227 in combination with Standard of Care (SoC) or other agents in participants with advanced solid tumors

GSK study ID
300148
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2025-522274-37-00
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 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in combination with Standard of Care (SoC) or other agents in Participants with Advanced Solid Tumors
Trial description: The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications

Timeframe: Up to approximately 31 weeks

Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity

Timeframe: Up to approximately 31 weeks

Number of participants with dose limiting toxicities (DLTs)

Timeframe: Up to approximately 31 weeks

Number of participants with clinically significant changes in Vital Signs, Body Weight, Laboratory Tests [Hematology, Clinical Chemistry, Urinalysis], Cardiac Function [ECG], and Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Up to approximately 31 weeks

Secondary outcomes:

Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)

Timeframe: Up to approximately 112 weeks

Number of participants with anti-drug antibody (ADA) against GSK5764227

Timeframe: Up to approximately 112 weeks

Number of participants with neutralising antibody (NAb) against GSK5764227

Timeframe: Up to approximately 112 weeks

Titer of ADA against GSK5764227

Timeframe: Up to approximately 112 weeks

Objective Response Rate (ORR)

Timeframe: Up to approximately 112 weeks

Disease control Rate (DCR18)

Timeframe: Up to approximately 112 weeks

Duration of Response (DoR)

Timeframe: Up to approximately 112 weeks

Progression free survival (PFS)

Timeframe: Up to approximately 112 weeks

Radiographic progression-free survival (rPFS)

Timeframe: Up to approximately 112 weeks

Prostate-specific antigen 50 (PSA50)

Timeframe: Up to approximately 112 weeks

Interventions:
  • Drug: GSK5764227
  • Drug: Bevacizumab
  • Drug: Fluorouracil
  • Drug: leucovorin
  • Drug: Enzalutamide
    • Enrollment:
    72
    Primary completion date:
    2026-13-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2025 to September 2028
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
    • Has adequate organ function.
    • 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 disease.
    • Has had any major surgery within 28 days prior to first dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.

      • Has adequate organ function.
      • Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum. (Cohort A)
      • Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B)
    Exclusion criteria:

      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 disease.

      • Has had any major surgery within 28 days prior to first dose.
      • Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
      • Has serious infection within 4 weeks prior to the first dose,
      • Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
      • Any evidence of current interstitial lung disease (ILD) or pneumonitis OR a prior history of ILD requiring high-dose glucocorticoids or non-infectious pneumonitis requiring high-dose glucocorticoids.
      • Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
      • Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term [30 days or longer]). Low-dose corticosteroids (prednisone ≤10 milligrams (mg)/day or equivalent) may be administered.

    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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