NCT06726369

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors.

Detailed description

This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors. The primary objectives are to evaluate the safety and tolerability of MK-6204. The secondary endpoints include PK parameters, ORR, DOR, and immunogenicity of MK-6204. The study will include a Screening Phase, a Treatment Phase, and a Post-treatment Follow up Phase.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	MK-6204 (SKB535) for Injection	MK-6204 (SKB535) for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Timeline

• Start date: 2024-12-12
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2024-12-10
• Last updated: 2025-03-13

Locations

7 sites across 1 country: China