Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.
- EligibilityCriteria: Inclusion Criteria:  Aged 18 and older. Capable of giving signed informed consent. Diagnosed with particular disease characteristics. Expected survival ≥ 3 months. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. A female patient is eligible to participate if she is not pregnant or breastfeeding. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy. Have measurable disease by revised RECIST v1.1 criteria.  Exclusion Criteria:  Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption. Current enrollment or past participation in another clinical trial. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy. Autologous transplantation within 60 days. Prior allogeneic transplantation. Major surgery within 30 days, or unresolved complications after a major or minor surgery. History of or currently active cardiovascular disease. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. History of other malignancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult