Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Intravenous infusion, once every 2 weeks, 4 weeks/cycle.
Intravenous infusion, once every 4 weeks, 4 weeks/cycle.
Zhongshan Hospital, Fudan University
Shanghai, China
Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events
To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC
Time frame: 28 Days
Phase Ib: Dose Exploration Part-Safety
To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.
Time frame: 2 years
Phase II: Dose Expansion Part-objective response rate (ORR)
To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)
Time frame: 2 years
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