Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma
Official Title: 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
Study ID: NCT04653038
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
The first hospital of Jilin University, Chang chun, Jilin, China
Jilin Cancer Hospital, Changchun, Jilin, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Tangdu Hospital, Xi'an, Shanxi, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Sir Run Shaw Hospital, School Of Medicine ,Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Jun GUO
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
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