BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT06111326

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-05-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BC3402+Durvalumab

Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Group Type: EXPERIMENTAL

BC3402 injection

Intervention Type: DRUG

Intravenous infusion, once every 2 weeks, 4 weeks/cycle.

Durvalumab injection

Intervention Type: DRUG

Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Interventions

BC3402 injection

Intravenous infusion, once every 2 weeks, 4 weeks/cycle.

Intervention Type: DRUG

Durvalumab injection

Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocity Biopharmaceutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Countries

China

Central Contacts

Jia Fan, MD

Role: CONTACT

fan.jia@zs-hospital.sh.cn

+86021-64041990

Tianshu Liu, MD

Role: CONTACT

liu.tianshu@zs-hospital.sh.cn

+86 13681973996

Facility Contacts

Tianshu Liu, MD

Role: primary

liu.tianshu@zs-hospital.sh.cn

+86 13681973996

Other Identifiers

BC3402-105

Identifier Type: -

Identifier Source: org_study_id