Spots Global Cancer Trial Database for A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

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Trial Identification

Brief Title: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Official Title: A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Study ID: NCT05417932

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma

Hepatocellular Carcinoma Recurrent

Interventions

SCG101

Study Description

Brief 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

Detailed Description: This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels. In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.