NCT07019779

Study of CM518D1 in Patients With Advanced Solid Tumors

A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	CM518D1	CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
BIOLOGICAL	CM518D1	CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
BIOLOGICAL	CM518D1	CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

Timeline

• Start date: 2025-06-27
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-06-13
• Last updated: 2025-11-17

Locations

1 site across 1 country: China