JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma
A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma(HCC)
Shanghai Junshi Bioscience Co., Ltd.
72 participants
May 29, 2025
INTERVENTIONAL
Conditions
Summary
This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC. The subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.
Eligibility
Plain Language Summary
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Interventions
10 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies.
Dose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage.
Locations(12)
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NCT06954467