Menu
Recruiting NCT07277270

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

Phase I Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GSK5764227, Bevacizumab, Fluorouracil, leucovorin.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b/2 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

Overview

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.

Interventions

  • Drug GSK5764227
    Participants will receive GSK5764227.
  • Drug Bevacizumab
    Participants will receive bevacizumab.
  • Drug Fluorouracil
    Participants will receive fluorouracil.
  • Drug leucovorin
    Participants will receive leucovorin.
  • Drug Enzalutamide
    Participants will receive enzalutamide.

Primary outcome measures

  • Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications [Time frame: Up to approximately 31 weeks]
  • Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity [Time frame: Up to approximately 31 weeks]
  • Number of participants with dose limiting toxicities (DLTs) [Time frame: 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 status [Time frame: Up to approximately 31 weeks]
Secondary outcome measures (10)
  • Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810) [Time frame: Up to approximately 112 weeks]
  • Number of participants with anti-drug antibody (ADA) against GSK5764227 [Time frame: Up to approximately 112 weeks]
  • Number of participants with neutralising antibody (NAb) against GSK5764227 [Time frame: Up to approximately 112 weeks]
  • Titer of ADA against GSK5764227 [Time frame: Up to approximately 112 weeks]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 112 weeks]
  • Disease control Rate (DCR18) [Time frame: Up to approximately 112 weeks]
  • Duration of Response (DoR) [Time frame: Up to approximately 112 weeks]
  • Progression free survival (PFS) [Time frame: Up to approximately 112 weeks]
  • Radiographic progression-free survival (rPFS) [Time frame: Up to approximately 112 weeks]
  • Prostate-specific antigen 50 (PSA50) [Time frame: Up to approximately 112 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 4 centers
  • GSK Investigational Site — Barcelona
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Málaga
United States · 1 center
  • GSK Investigational Site — Lake Success
Australia · 1 center
  • GSK Investigational Site — Tugun

Identifiers

NCT: NCT07277270 · 300148 · 2025-522274-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗