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
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 and older. 2. Capable of giving signed informed consent. 3. Diagnosed with particular disease characteristics. 4. Expected survival ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 6. A female patient is eligible to participate if she is not pregnant or breastfeeding. 7. 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. 8. Have measurable disease by revised RECIST v1.1 criteria. Exclusion Criteria: 1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption. 2. Current enrollment or past participation in another clinical trial. 3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy. 4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy. 5. Autologous transplantation within 60 days. 6.