A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- Trial number:
- NCT05417932
- Trial phase:
- 1, 2
- Study type:
- Immunotherapy
- Overall status:
- Recruiting
Study start date
October, 2022
Scientific title
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Summary
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
Main
Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)Subjects with HCC who have received at least 2 standard systemic therapies HLA-A *02 BCLC stage B or C Child-pugh score ≤ 7 Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria Life expectancy of 3 months or greater Ability to provide informed consent form Ability to comply with all the study procedures
Main
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Intervention model description:
SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma, Masking:
None (Open Label),
Conditions
Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent
Other study ID numbers
SCG101-UR-103