NCT06868199

A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: LaNova Medicines Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours. For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	LM-168	Q3W,Intravenous Drip
DRUG	Toripalimab	Q3W,Intravenous

Timeline

• Start date: 2025-05-06
• Primary completion: 2027-08-01
• Completion: 2028-02-01
• First posted: 2025-03-10
• Last updated: 2025-09-12

Locations

6 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study