drugset / Trial / NCT04501770

A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors

NCT04501770 ↗

Phase 1 Completed 34 enrolled Wuhan YZY Biopharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).

Timeline

Start
2018-09-27
Primary completion
2022-05-06
Completion
2022-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject M802 Monoclonal antibody 5 ug Intravenous
Subject M802 Monoclonal antibody 10 ug Intravenous
Subject M802 Monoclonal antibody 20 ug Intravenous
Subject M802 Monoclonal antibody 50 ug Intravenous
Subject M802 Monoclonal antibody 100 ug Intravenous
Subject M802 Monoclonal antibody 150 ug Intravenous
Subject M802 Monoclonal antibody 225 ug Intravenous
Subject M802 Monoclonal antibody 300 ug Intravenous

Indications

No indication recorded.