Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
NCT07215637 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-02-02
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.
Conditions
- Advanced Solid Tumors
- Metastatic Solid Tumors
Interventions
- DRUG
-
CKD-512
Orally administered BID
- COMBINATION_PRODUCT
-
Pembrolizumab
Intravenous (IV) Infusion
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-16
- Primary Completion
- 2027-03-31
- Completion
- 2027-09-30
Countries
- South Korea
Study Locations
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