Clinical trial · Interventional
Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD-512 | Drug | — | UNRESOLVED |
| Pembrolizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Monotherapy
- description
- Dose Level(DL) 1 to DL 6
- interventionNames
- Drug: CKD-512
- type
- EXPERIMENTAL
- label
- Part B: Combination therapy
- description
- DL N to DL N+2, combination with Pembrolizumab
- interventionNames
- Drug: CKD-512
- Combination Product: Pembrolizumab
Primary outcomes (2)
- measure
- Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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).
References
Publications (0)
Data not yet available