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.
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.
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
Sequential
CKD-512
DrugOrally administered BID
Pembrolizumab
Combination productIntravenous (IV) Infusion
Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
Part B: Recommended dose for expansion (RDE)
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
Safety and tolerability
Incidence and severity of TEAEs, incidence of SAEs and TRAEs etc. according to the NCI-CTCAE version 5.0
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration of CKD-512
Cmax at steady state (Cmax_ss)
Cmax\_ss is defined as the maximum observed plasma concentration of CKD-512 at steady state
Area Under the Curve to the last measurable concentration (AUClast)
AUClast is defined as the area under the plasma concentration-time curve of CKD-512 from the time of dosing to the time of the last measurable concentration.
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