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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
A fixed dose of MGD013 600mg IV Q2W will be administered to subjects
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Objective Response Rate (ORR)
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
Time frame: Approximately 12 months after dosed
Objective Response Rate (ORR)
Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1
Time frame: Approximately 12 months after dosed
Objective Response Rate (ORR)
Objective Response Rate (ORR) as assessed by Investigator and IRC per irRECIST.
Time frame: Approximately 12 months after dosed
Overall Survival (OS)
Overall Survival (OS) is defined as the time from patient enrollment to death due to any cause
Time frame: Approximately 24 months
Progression-free Survival (PFS)
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
Time frame: Approximately 12 months after dosed
Disease Control Rate (DCR)
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
Time frame: Approximately 12 months after dosed
Duration of Response (DoR)
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
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Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The first hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tangdu Hospital
Xi’an, Shanxi, China
...and 3 more locations
Time frame: Approximately 12 months after dosed
Survival Rate
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
Time frame: Approximately 12 months after dosed
Incidence of Abnormal Laboratory value
Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value not prior to the initiation of MGD013 administration
Time frame: Approximately 24 months
Incidence of Adverse Events
The incidence of adverse events is defined as the proportion of the patients who have adverse event(s) enrolled in this study.
Time frame: Approximately 24 months
Incidence of Treatment-Emergent Adverse Events
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.
Time frame: Approximately 24 months.
Maximum Serum Concentration (Cmax)
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.
Time frame: Approximately 3 months.
Trough Serum Concentration (Ctrough)
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.
Time frame: Approximately 3 months
Immunogenicity of MGD013
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.
Time frame: Approximately 6 months after dosed