NCT04737122

Study of LM-061 in Subjects in Advanced Tumors

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

• Status: Terminated
• Phase: Phase 1
• 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, open-label, dose escalation 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, open-label, dose escalation 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	Oral dose with approximately 240 mL water in the fasting condition, and food will be forbidden 1 h prior to administration and 2h after dose. QD for continuous 28 days, and 4 weeks as one treatment cycle.
DRUG	Toripalimab	For subjects in combination escalation levels, toripalimab will be administered 240mg, IV, every 3 weeks

Timeline

• Start date: 2021-05-06
• Primary completion: 2022-07-19
• Completion: 2022-12-01
• First posted: 2021-02-03
• Last updated: 2023-10-10

Locations

1 site across 1 country: Australia