Status:
NOT_YET_RECRUITING
BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Biocity Biopharmaceutics Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 carc...
Eligibility Criteria
Inclusion
- Willing to participate in the study and sign an informed consent form;
- Male or female aged ≥ 18 years and ≤ 75 years;
- Patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by American Association for the Study of Liver Disease (AASLD) (2018 edition);
- ECOG performance status of 0 or 1;
- HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment;
- Adequate organ and marrow function;
- Male or female subjects with childbearing potential must agree to use reliable contraceptive methods.
Exclusion
- Received local hepatic therapy within 4 weeks prior to initiation of the study drug;
- History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy;
- The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage.
- The subject has main portal vein thrombosis on baseline imaging;
- Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement;
- Current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug;
- Prior treatment with any anti-TIM3 antibody;
- Prior treatment with an anti-PD-1 or anti PD-L1 immune checkpoint inhibitor antibody (only applicable for dose expansion part).
- Other protocol-defined Inclusion/Exclusion may apply.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06111326
Start Date
October 1 2023
End Date
May 1 2026
Last Update
November 1 2023
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China