Actively Recruiting
Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
Led by Chong Kun Dang Pharmaceutical · Updated on 2026-02-02
60
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic solid tumors.
- Disease progression after or intolerance to standard therapy with no other effective treatment options.
- Measurable disease according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Suitable venous access for blood sampling including pharmacokinetic and pharmacodynamic tests.
- Adequate clinical laboratory values and other health measures.
You will not qualify if you...
- Active involvement of the central nervous system by disease.
- Serious or life-threatening medical conditions unrelated to cancer, psychiatric illness, or drug/alcohol abuse that could interfere with treatment.
- Use of systemic anticancer treatment within the protocol-specified period before the first dose.
- History of immune-related toxicity causing permanent stop of prior anticancer therapy.
- Radiation therapy to a limited area within 4 weeks before the first dose unless the lesion is stable.
- Prior treatment with investigational agents within 21 days before the first dose of study drugs.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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