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
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.
Arms & 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.
Outcome measures
Primary
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
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
Study locations (1)
GSK Investigational Site
Lake Success, New York, 11042