NCT04882176

A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: LaNova Medicines Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

Detailed description

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors. The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).

Conditions

• Advanced Tumours

Interventions

Type	Name	Description
DRUG	LM-061	The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-02-07
• Completion: 2023-07-19
• First posted: 2021-05-11
• Last updated: 2023-07-27

Locations

1 site across 1 country: China