BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

Launched by BIOCITY BIOPHARMACEUTICS CO., LTD. · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced liver cancer, known as hepatocellular carcinoma (HCC). It is testing a combination of two drugs: BC3402 and durvalumab. The goal is to find out how safe this combination is and to determine the best dose to use in future studies. In the first part of the trial, researchers will explore different doses to see how well patients tolerate the treatment, and in the second part, they will look at how effective it is in fighting the cancer.

To participate in this study, you need to be between 18 and 75 years old and have a confirmed diagnosis of advanced liver cancer. You also should be in good health overall, with no recent serious liver complications. If you have a viral infection like hepatitis B, it needs to be treated before you can join. Participants will be closely monitored throughout the trial, and they will need to agree to use reliable birth control if they are able to have children. Keep in mind that the trial is not yet recruiting, so it won’t be starting right away. If you or a loved one are considering this option, it’s important to discuss it with your healthcare provider to understand if it’s a good fit.

Gender

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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.