Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Summary

Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid tumors

Timeline

Start

2020-11-24

Primary completion

2023-11-04

Completion

2023-11-04

Publications

• Cheng Y, Wu C, Wu L, Zhao J, Zhao Y, Chen L, Xin Y, Zhang L, Pan P, Li X, Li J, Dong X, Tang K, Gao E, Yu F. A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer. Sci Rep. 2024 Feb 13;14(1):3598. doi: 10.1038/s41598-024-54223-5.

Drugs

Indications