JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors

Phase 1 Unknown 50 enrolled Peking University RemeGen Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors.

Timeline

Start: 2020-06-03
Primary completion: 2024-12
Completion: 2024-12

Publications

Wang Y, Gong J, Wang A, Wei J, Peng Z, Wang X, Zhou J, Qi C, Liu D, Li J, Lu M, Lu Z, Cao Y, Yuan J, Zhang R, Fang J, Zhang X, Shen L. Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial. EClinicalMedicine. 2024 Jan 5;68:102415. doi: 10.1016/j.eclinm.2023.102415. eCollection 2024 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Disitamab Vedotin	Monoclonal antibody	2 mg/kg	—
Subject	Disitamab Vedotin	Monoclonal antibody	2.5 mg/kg	—
Subject	Toripalimab	Monoclonal antibody	3 mg/kg	—

Indications

No indication recorded.