Spots Global Cancer Trial Database for A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
Official Title: An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
Study ID: NCT04843709
Conditions
Interventions
Study Description
Brief Summary: The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.
Detailed Description: This study consists of two parts. Part A is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A. Part B is a disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chao Family Comprehensive Cancer Center, Orange, California, United States
Memorial Sloan Kettering 60th Street Outpatient Center, New York, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
The Christ Hospital Cancer Center, Cincinnati, Ohio, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Hunan Cancer Hospital, Changsha, Hunan, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Contact Details
Name: Nashat Y Gabrail, MD
Affiliation: Gabrail Cancer Center Research
Role: PRINCIPAL_INVESTIGATOR
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