GSK5764227 given with standard therapies for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase (Phase 1) trial testing GSK5764227 in combination with standard-of-care agents like bevacizumab, fluorouracil/leucovorin, or enzalutamide in participants with advanced solid tumors. The study will use dose-escalation and expansion cohorts to define safety, tolerability, and how the body processes the drug (pharmacokinetics). Researchers will also monitor for immune responses to the drug and look for signs that tumors shrink or stop growing. Participants will be closely followed for side effects and treatment-related complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• GSK Investigational Site
  Reunion, Florida, United States Recruiting
• GSK Investigational Site
  New Hyde Park, New York, United States Recruiting
• GSK Investigational Site
  Philadelphia, Pennsylvania, United States Recruiting
• GSK Investigational Site
  Nashville, Tennessee, United States Recruiting
• GSK Investigational Site
  Dallas, Texas, United States Recruiting
• GSK Investigational Site
  Douglas, Queensland, Australia Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.