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