A Phase Ib/II 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

Study Identifier:
300148
CT.gov Identifier:
NCT07277270
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-522274-37-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Neoplasms
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Metastatic castration-resistant prostate cancer (mCRPC) cohort B
    • Read More
  • Drug: Drug: Enzalutamide
  • Drug: Participants will receive enzalutamide.
  • Drug: Drug: GSK5764227
  • Drug: Participants will receive GSK5764227.
  • Drug: EXPERIMENTAL: Metastatic colorectal cancer (mCRC) cohort A1
  • Drug: Drug: Bevacizumab
  • Drug: Participants will receive bevacizumab.
  • Drug: EXPERIMENTAL: Metastatic colorectal cancer (mCRC) cohort A2
  • Drug: Drug: Fluorouracil
  • Drug: Participants will receive fluorouracil.
  • Drug: Drug: leucovorin
  • Drug: Participants will receive leucovorin.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Recruiting
    Condition(s) Treated at Site
    Neoplasms
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan José Soto
    Status
    Recruiting
    Condition(s) Treated at Site
    Neoplasms
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Neoplasms