Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors

Phase 1 Completed 57 enrolled RemeGen Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.

Timeline

Start: 2015-12-14
Primary completion: 2019-06-27
Completion: 2019-11-08

Publications

Xu Y, Wang Y, Gong J, Zhang X, Peng Z, Sheng X, Mao C, Fan Q, Bai Y, Ba Y, Jiang D, Yang F, Qi C, Li J, Wang X, Zhou J, Lu M, Cao Y, Yuan J, Liu D, Wang Z, Fang J, Shen L. Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors. Gastric Cancer. 2021 Jul;24(4):913-925. doi: 10.1007/s10120-021-01168-7. Epub 2021 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Disitamab Vedotin	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	1.5 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	2.5 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	3.5 mg/kg	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	4 mg/kg	Intravenous

Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors

Summary

Timeline

Publications

Drugs

Indications