The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Drug: SHR-1701 IV infusion Drug: BP102 IV infusion Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, China
recommended phase 2 dose (Phase Ib)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
Time frame: 2 years
Dose Limiting Toxicity (DLT) (Phase 1b)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: For each participant, from the first dose till 90 days after the last dose
Number of participants with treatment emergent serious adverse events (SAEs)
Time frame: For each participant, from the first dose till 90 days after the last dose
ORR
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Time to response(TTR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
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