Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CKD-512, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors, Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug CKD-512
Orally administered BID - Combination product Pembrolizumab
Intravenous (IV) Infusion
Primary outcome measures
- Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED) [Time frame: Up to 2 years]
- Part B: Recommended dose for expansion (RDE) [Time frame: Up to 2 years]
Secondary outcome measures (9)
- Safety and tolerability [Time frame: Up to 2 years]
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to 2 years]
- Cmax at steady state (Cmax_ss) [Time frame: Up to 2 years]
- Area Under the Curve to the last measurable concentration (AUClast) [Time frame: Up to 2 years]
- Area Under the Curve over the dosing interval tau (AUCtau) [Time frame: Up to 2 years]
- Overall Response Rate (ORR) [Time frame: Up to 2 years]
- Duration of Response (DOR) [Time frame: Up to 2 years]
- Disease Control Rate (DCR) [Time frame: Up to 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance Hospital, Yonsei University Health System — Seoul
Identifiers
NCT: NCT07215637 · A150_01ST2410