The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Dose limiting toxicity (DLT) and adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: From subject sign the ICF to 30 days after the last dose of study treatment
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.
Time frame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Prostate-specific antigen (PSA) response rate (Cohort D)
The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart
Time frame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
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