Who is sponsoring NCT04212221?

NCT04212221 is sponsored by Zai Lab (Shanghai) Co., Ltd..

What condition does NCT04212221 study?

NCT04212221 studies Advanced Hepatocellular Carcinoma (HCC).

What drugs are being tested in NCT04212221?

Interventions: MGD013 monotherapy, MGD013 in combination with Brivanib Alaninate.

What is the status of NCT04212221?

NCT04212221 is currently TERMINATED.

Last reviewed 2024-07-23 · How we verify

MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients

NCT04212221 PHASE1, PHASE2 TERMINATED Results posted

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.

Details

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	PHASE1, PHASE2
Status	TERMINATED
Enrolment	89
Start date	Mon Apr 20 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Apr 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Interventions

MGD013 monotherapy
MGD013 in combination with Brivanib Alaninate

Countries

China