About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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,
Trial design
Sequential
Treatments tested in this trial
GSK5764227
DrugParticipants will receive GSK5764227.
Bevacizumab
DrugParticipants will receive bevacizumab.
Fluorouracil
DrugParticipants will receive fluorouracil.
leucovorin
DrugParticipants will receive leucovorin.
Enzalutamide
DrugParticipants will receive enzalutamide.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications
Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity
Number of participants with dose limiting toxicities (DLTs)
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
Secondary outcomes
Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)
Number of participants with anti-drug antibody (ADA) against GSK5764227
Number of participants with neutralising antibody (NAb) against GSK5764227
Titer of ADA against GSK5764227
Sponsors and contacts
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