Hepatocellular Carcinoma
Conditions
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 carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.
Interventions
DRUGBC3402 injection
Intravenous infusion, once every 2 weeks, 4 weeks/cycle.
Intravenous infusion, once every 4 weeks, 4 weeks/cycle.
Sponsors
Biocity Biopharmaceutics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to participate in the study and sign an informed consent form; 2. Male or female aged ≥ 18 years and ≤ 75 years; 3. 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); 4. ECOG performance status of 0 or 1; 5. HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment; 6. Adequate organ and marrow function; 7. Male or female subjects with childbearing potential must agree to use reliable contraceptive methods.
Exclusion criteria
1. Received local hepatic therapy within 4 weeks prior to initiation of the study drug; 2. History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy; 3. The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage. 4. The subject has main portal vein thrombosis on baseline imaging; 5. Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement; 6. Current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug; 7. Prior treatment with any anti-TIM3 antibody; 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events | 28 Days | 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 |
| Phase Ib: Dose Exploration Part-Safety | 2 years | To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC. |
| Phase II: Dose Expansion Part-objective response rate (ORR) | 2 years | To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1) |
Countries
China
Contacts
Primary ContactJia Fan, MD
Backup ContactTianshu Liu, MD
Outcome results
None listed