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

NCT04653038 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-01-29

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

MGD013

A fixed dose of MGD013 600mg IV Q2W will be administered to subjects

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jun GUO · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-29
Primary Completion
2022-03-02
Completion
2022-03-02
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653038 on ClinicalTrials.gov