BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

Phase 1

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: BC3402 injection; Drug: Durvalumab injection

• Registration Number: NCT06111326
• Lead Sponsor: Biocity Biopharmaceutics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-08
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BC3402+Durvalumab	BC3402 injection	Subjects will receive BC3402 and Durvalumab in a treatment cycle.
BC3402+Durvalumab	Durvalumab injection	Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Primary Outcome Measures

Name	Time	Method
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 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)
Phase Ib: Dose Exploration Part-Safety	2 years	To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China