clinical trial · 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
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·phase1·recruiting·n = 90
Advanced Solid TumorsMK-6204 (SKB535) for Injection
brief 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.
started
Dec 12, 2024
primary completion
Dec 31, 2029
completion
Dec 31, 2029
last updated
Mar 13, 2025
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.
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