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Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
Sponsor: Chong Kun Dang Pharmaceutical
Summary
The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.
Official title: A Multicenter, Open-label, Dose-escalation, Phase Ia/Ib Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-16
Completion Date
2027-09
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
CKD-512
Orally administered BID
Pembrolizumab
Intravenous (IV) Infusion
Locations (1)
Severance Hospital, Yonsei University Health System
Seoul, South Korea