Status:
NOT_YET_RECRUITING
Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Advanced Solid Tumors
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 w...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced or metastatic solid tumors.
- Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.
- Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Suitable venous access for the study-required blood sampling, including PK and PD sampling.
- Adequate clinical laboratory values and other measures
Exclusion
- Active disease involvement of the central nervous system.
- Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Systemic anticancer treatment within the protocol-specified period prior to the first dose.
- History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy
- Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.
- Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07215637
Start Date
October 1 2025
End Date
September 1 2027
Last Update
October 10 2025
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea