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A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-12-12
Completion Date
2029-12-31
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (10)
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Beijing Cancer Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Provincial Cancer Hospital
Fuzhou, China
Linyi Cancer Hospital
Linyi, China
Shanghai East Hospital
Shanghai, China
Hubei Cancer Hospital
Wuhan, China