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Study of GSK5764227 for Advanced Solid Tumors

This study is testing a new drug called GSK5764227, which is designed to deliver a toxin directly to cancer cells while leaving healthy cells alone. Researchers will combine GSK5764227 with standard treatments like bevacizumab, fluorouracil, leucovorin, or enzalutamide. The main goals are to see how safe GSK5764227 is, how your body handles it, if it causes any immune reactions, and if it can shrink or control advanced solid tumors. You might be able to join if you have advanced colon, rectal, or prostate cancer that cannot be removed by surgery, are at least 18 years old, and have a good performance status (meaning you can do most daily activities). The study aims to enroll 84 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 84 participants to evaluate the new drug in combination with standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) and dose-limiting toxicities for up to approximately 31 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07277270

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~84 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:GSK5764227BevacizumabFluorouracilleucovorinEnzalutamide

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications
Measured over Up to approximately 31 weeks
+3 more outcomes measured

Conditions

Neoplasms

Explore related trials

Colorectal CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

6 sites across 3 states
Spain4
New York1
Queensland1

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modificationsUp to approximately 31 weeks
  • Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severityUp to approximately 31 weeks
  • Number of participants with dose limiting toxicities (DLTs)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 statusUp to approximately 31 weeks