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
GlaxoSmithKline
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
- Age range
- 18+ years
- Sex
- All
- 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 carcinom…
Interventions
- DrugGSK5764227
Participants will receive GSK5764227.
- DrugBevacizumab
Participants will receive bevacizumab.
- DrugFluorouracil
Participants will receive fluorouracil.
- Drugleucovorin
Participants will receive leucovorin.
- DrugEnzalutamide
Participants will receive enzalutamide.
Locations (6)
- GSK Investigational SiteLake Success, New York
- GSK Investigational SiteTugun, Queensland
- GSK Investigational SiteBarcelona
- GSK Investigational SiteMadrid
- GSK Investigational SiteMadrid
- GSK Investigational SiteMálaga