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Brief Title: A Study of MRG003 in Patients With Advanced Solid Tumors
Official Title: An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.
Study ID: NCT04868344
Brief Summary: The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.
Detailed Description: This study consists of two parts: Phase Ia dose escalation and Phase Ib dose expansion. The objective of Phase Ia is to determine MTD or RP2D, and Phase Ib is conducted to evaluate efficacy of MRG003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Name: Ruihua Xu, M.D.
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR