Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

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.

Zai Lab (Shanghai) Co., Ltd.

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Laryngeal Cancer

Antibodies

Immunomodulating Agents

Immunoglobulins

Mitoguazone

enoblituzumab

MGA012

This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).

Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.

Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck

A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1

Evaluation of adverse events and serious adverse events

Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment

Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013

Maximum serum concentration of enoblituzumab and MGA012

Trough serum concentration of enoblituzumab and MGA012

Maximum serum concentration of enoblituzumab and MGD013

Trough serum concentration of enoblituzumab and MGD013

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck	NCT04129320	Head and Neck C... Squamous Cell C...	enoblituzumab MGA012 MGD013	18 Years -	MacroGenics

Spots Global Cancer Trial Database for mgd013

Every month we try and update this database with for mgd013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mgd013

Every month we try and update this database with for mgd013 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mgd013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.