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:
NA, Intervention model:
SINGLE_GROUP, Intervention model description:
SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma, Masking:
NONE,
Conditions
Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent
Other study ID numbers
SCG101-UR-103
Choose trial site (8)
New York
New York, NY 10029, USA
New York
New York, NY 10065, USA
Hong Kong
Hong Kong
Singapore
Singapore 119074
National Cancer Centre Singapore
Singapore 169610
Hong Kong is.
Hong Kong
Hong Kong NT
New Territories, Hong Kong
Singapore
Singapore 228510