MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This study consists of two parts: Phase I is a dose escalation study to determine the
Recommended Phase II Dose (RP2D) of MGD013 monotherapy and that of MGD013 when in combination
with Brivanib Alaninate (ZL-2301) in subjects with advanced liver cancer (including
hepatocellular carcinoma and intrahepatic cholangiocarcinoma). Phase II is a dose expansion
study and consists of two parts: Part 1 is to assess the safety and efficacy of MGD013
monotherapy and MGD013 in combination with ZL-2301 in subjects with advanced hepatocellular
carcinoma (HCC); in Part 2, a therapeutic method (MGD013 monotherapy or MGD013 in combination
with ZL-2301, determined by the sponsor according to the obtained data) will be selected for
dose expansion study in HCC subjects who have previously failed immune checkpoint inhibitor
treatment, to further evaluate the safety and efficacy of the study treatments in the
specific group of subjects.