Clinical Trials in Australia / NCT07277270
Recruiting Phase 1

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

NCT07277270 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2025-12-03
Last updated
2026-09-25

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

GSK5764227 →Bevacizumab →Fluorouracil →leucovorin →Enzalutamide →

GSK5764227: Participants will receive GSK5764227.

Bevacizumab: Participants will receive bevacizumab.

Fluorouracil: Participants will receive fluorouracil.

leucovorin: Participants will receive leucovorin.

Enzalutamide: Participants will receive enzalutamide.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
GSK Investigational Site Reunion Florida Recruiting
GSK Investigational Site New Hyde Park New York Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site Nashville Tennessee Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site Douglas Queensland Recruiting
GSK Investigational Site Tugun Queensland Recruiting
GSK Investigational Site Geelong Victoria Recruiting
GSK Investigational Site Bendigo Australia Recruiting
GSK Investigational Site Ottawa Ontario Recruiting
GSK Investigational Site Toronto Ontario Recruiting
GSK Investigational Site Seoul South Korea Recruiting
GSK Investigational Site Seoul South Korea Recruiting
GSK Investigational Site Seoul South Korea Recruiting
GSK Investigational Site Barcelona Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Málaga Spain Recruiting
GSK Investigational Site Leicester United Kingdom Recruiting
GSK Investigational Site London United Kingdom Recruiting
GSK Investigational Site Sutton United Kingdom Recruiting

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Xtandi (enzalutamide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07277270 on ClinicalTrials.gov ↗ ← All trials in Australia