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NCT07277270PHASE1Recruiting

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

GlaxoSmithKline

Start Date

12/3/2025

Completion Date

5/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

GSK5764227

DRUG

Bevacizumab

DRUG

Fluorouracil

DRUG

leucovorin

DRUG

Enzalutamide

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Conditions

Neoplasms

Locations

GSK Investigational Site

Reunion, Florida 34747-4606

United States

GSK Investigational Site

New Hyde Park, New York 11042-1118

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19107

United States

GSK Investigational Site

Nashville, Tennessee 37203

United States

GSK Investigational Site

Dallas, Texas 75230

United States

GSK Investigational Site

Douglas, Queensland 4814

Australia

GSK Investigational Site

Tugun, Queensland 4224

Australia

GSK Investigational Site

Geelong, Victoria 3220

Australia

GSK Investigational Site

Bendigo, VIC 3550

Australia

GSK Investigational Site

Ottawa, Ontario K1H 8L6

Canada

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 138-736

South Korea

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Madrid, 28034

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28050

Spain

GSK Investigational Site

Málaga, 29010

Spain

GSK Investigational Site

Leicester, LE1 5WW

United Kingdom

GSK Investigational Site

London, W12 0NN

United Kingdom

GSK Investigational Site

Sutton, SM2 5PT

United Kingdom