BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

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 Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: BC3402 injection; Drug: Durvalumab injection

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jia Fan, MD; Phone Number: +86021-64041990; Email: fan.jia@zs-hospital.sh.cn
• Study Contact Backup: Name: Tianshu Liu, MD; Phone Number: +86 13681973996; Email: liu.tianshu@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University
    • Contact: Tianshu Liu, MD; Phone Number: +86 13681973996; Email: liu.tianshu@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BC3402+Durvalumab; Subjects will receive BC3402 and Durvalumab in a treatment cycle.	Drug: BC3402 injection; Intravenous infusion, once every 2 weeks, 4 weeks/cycle.; Drug: Durvalumab injection; Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 Days
Phase Ib: Dose Exploration Part-Safety	To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.	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)	2 years

Collaborators and Investigators

• Sponsor: Biocity Biopharmaceutics Co., Ltd.
• Investigators: Principal Investigator: Jia Fan, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: BC3402-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No