BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06111326
• Other study ID #: BC3402-105
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2023
• Est. completion date: May 2026

Study information

• Verified date: October 2023
• Source: Biocity Biopharmaceutics Co., Ltd.
• Contact: Jia Fan, MD
• Phone: +86021-64041990
• Email: fan.jia[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 83
• Est. completion date: May 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• BC3402 injection
Intravenous infusion, once every 2 weeks, 4 weeks/cycle.
• Durvalumab injection
Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Biocity Biopharmaceutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Phase Ib: Dose Exploration Part-Safety	To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.	2 years
Primary	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