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

Advanced Solid Tumor Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

To evaluate the safety and tolerability of PM01183 as a single agent, and to identify the dose limiting toxicities (DLTs), determine the recommended dose (RD) in Chinese advanced solid tumors patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04638491
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 24, 2020
Completion date November 4, 2023
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