A Study of MRG003 in Patients With Advanced Solid Tumors

Phase 1 Completed 61 enrolled Shanghai Miracogen Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2018-05-09
Primary completion: 2021-03-29
Completion: 2021-03-29

Publications

Qiu MZ, Zhang Y, Guo Y, Guo W, Nian W, Liao W, Xu Z, Zhang W, Zhao HY, Wei X, Xue L, Tang W, Wu Y, Ren G, Wang L, Xi J, Jin Y, Li H, Hu C, Xu RH. Evaluation of Safety of Treatment With Anti-Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1042-1046. doi: 10.1001/jamaoncol.2022.0503.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Becotatug Vedotin	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	0.6 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	2.5 mg/kg	Intravenous
Subject	Becotatug Vedotin	Monoclonal antibody	3 mg/kg	Intravenous

A Study of MRG003 in Patients With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications