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Clinical Trial Summary

This was a multicenter, open, multi-cohort extended PHASE I/IIa study, consisting of 2 phases:Phase I (Phase I dose escalation) and Phase II (Phase IIa multi-cohort extension). The objective of this study was to evaluate safety, tolerability, pharmacokinetic characteristics, and initial efficacy in malignant pleural mesothelioma and MSLN in advanced malignant solid tumors.


Clinical Trial Description

Phase I dose escalation phase:This study predicted a total of 6 dose groups, 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg. Phase IIa efficacy exploration phase:This phase is the multi-cohort indication expansion phase. Based on the data obtained in phase I, chose an appropriate dose continue to explore multi-cohort indications, including confirmed malignancy Pleural mesothelioma and MSLN expression were determined. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04175847
Study type Interventional
Source RemeGen Co., Ltd.
Contact Xiaohong Su, M.D.
Phone +0810-65391479
Email xiaohong.su@remegen.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date April 14, 2020
Completion date September 2025

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