NCT04212221

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

A Multicenter, Open-label, Phase I/II Dose Escalation and Expansion Clinical Study to Assess the Safety and Efficacy of MGD013 Monotherapy and in Combination With Brivanib Alaninate (ZL-2301) in Patients With Advanced Liver Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	MGD013 monotherapy	MGD013 monotherapy will start from Phase I dose escalation first, starting dose will be 120mg Q2W, the dose level may escalate sequentially following traditional 3+3 dose escalation scheme (120mg, 240mg, 400mg, 600mg) to determine the RP2D(recommended phase II dose) of MGD013 monotherapy. Then Phase II dose expansion study will initiate, patients will receive the fixed dose of MGD013 monotherapy with RP2D determined in Phase I study.
DRUG	MGD013 in combination with Brivanib Alaninate	After determining the RP2D of MGD013 monotherapy, MGD013 at the fixed dose will be combined with Brivanib Alaninate. Dose escalation study of the combination therapy in Phase I will adopt traditional 3+3 dose escalation scheme; the dosage of Brivanib will start from 200 mg QD, and may escalate to 400 mg QD, 600 mg QD and a maximum of 800 mg QD to to determine the RP2D of MGD013 in combination with Brivanib Alaninate. Then Phase II dose expansion study will initiate, patients will receive the fixed dose of MGD013 and Brivanib Alaninate combination therapy with RP2D determined in Phase I study.

Timeline

• Start date: 2020-04-20
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2019-12-26
• Last updated: 2024-07-23
• Results posted: 2024-07-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study