Symptoms and General Pathology

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Melanoma

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

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Acral Lentiginous Melanoma

Neuroendocrine Tumor

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Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Cohort1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy

Cohort2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma

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

MGD013

Jun GUO

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.

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.

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.

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

Objective Response Rate (ORR) is defined as the proportion of patients with a best response of CR or PR in enrolled patients, which is assessed by Independent Review Committee (IRC) per RECIST v1.1

Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1

Objective Response Rate (ORR) as assessed by Investigator and IRC per irRECIST.

Overall Survival (OS) is defined as the time from patient enrollment to death due to any cause

Progression-free Survival (PFS) is defined as the time from patient enrollment to tumor progression or death due to any cause. Progression is assessed per RECIST 1.1 and irRECIST criteria, respectively

Disease Control Rate (DCR) is defined as the time from patient enrollment to tumor progression or death due to any cause. The tumor progression is assessed per RECIST 1.1 and irRECIST criteria, respectively

Duration of Response (DoR) is defined as the time from radiographic response to disease progression or death in patients with a best response of CR or PR, assessed per RECIST 1.1 and irRECIST criteria, respectively

Survival Rate is defined as the proportion of surviving patients at the corresponding time point. Survival rates at 6 and 12 months will be analyzed in this study

Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value not prior to the initiation of MGD013 administration

The incidence of adverse events is defined as the proportion of the patients who have adverse event(s) enrolled in this study.

The incidence of treatment-emergent adverse event is defined as any event not present prior to the initiation of MGD013 treatment or any event already present that worsens in either intensity or frequency following exposure to MGD013 administration.

The maximum serum concentration (Cmax, ng/ml) is defined as the maximum (or peak) serum concentration that MGD013 achieves in patients after the MGD013 administration at a corresponding timepoint.

The through serum concentration (Cmin, ng/ml) is defined as the minimum (or through) serum concentration reached by MGD013 prior to administration of a second dose.

Immunogenicity is defined as the positivity measured as the anti-MGD013 antibody induced in serum after MGD013 is administrated into human body at corresponding timepoints.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma	NCT04653038	Unresectable, R... Untreated Mucos...	MGD013	18 Years -	Zai Lab (Hong Kong), Ltd.
A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma	NCT04653038	Unresectable, R... Untreated Mucos...	MGD013	18 Years -	Zai Lab (Hong Kong), Ltd.

Spots Global Cancer Trial Database for untreated mucosal or acral lentiginous melanoma