A study of GSK5764227 in combination with Standard of Care (SoC) or other agents in participants with advanced solid tumors
Trial overview
Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications
Timeframe: Up to approximately 31 weeks
Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity
Timeframe: Up to approximately 31 weeks
Number of participants with dose limiting toxicities (DLTs)
Timeframe: 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
Timeframe: Up to approximately 31 weeks
Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)
Timeframe: Up to approximately 112 weeks
Number of participants with anti-drug antibody (ADA) against GSK5764227
Timeframe: Up to approximately 112 weeks
Number of participants with neutralising antibody (NAb) against GSK5764227
Timeframe: Up to approximately 112 weeks
Titer of ADA against GSK5764227
Timeframe: Up to approximately 112 weeks
Objective Response Rate (ORR)
Timeframe: Up to approximately 112 weeks
Disease control Rate (DCR18)
Timeframe: Up to approximately 112 weeks
Duration of Response (DoR)
Timeframe: Up to approximately 112 weeks
Progression free survival (PFS)
Timeframe: Up to approximately 112 weeks
Radiographic progression-free survival (rPFS)
Timeframe: Up to approximately 112 weeks
Prostate-specific antigen 50 (PSA50)
Timeframe: Up to approximately 112 weeks
Participation 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 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 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)
Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
- 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.
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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.