NCT04653038

A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma

An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.

Detailed description

The study is conducted in two parts for both Cohort 1 and Cohort 2. Part I: Safety evaluation and efficacy exploration for MGD013. Part II: Efficacy expansion based on results from Part I to further evaluate the efficacy effect of MGD013.

Conditions

• Unresectable, Recurrent or Metastatic Melanoma
• Untreated Mucosal or Acral Lentiginous Melanoma

Interventions

Type	Name	Description
DRUG	MGD013	A fixed dose of MGD013 600mg IV Q2W will be administered to subjects

Timeline

• Start date: 2020-10-29
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2020-12-04
• Last updated: 2024-01-29

Locations

13 sites across 1 country: China

Regulatory

• FDA-regulated drug study