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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers |
|
| Combination with Pembrolizumab | Experimental | Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-4505 | Drug | Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria | The recommended Phase 2 dose(RP2D) will be the optimal biological dose (OBD) based on consideration of safety and tolerability information along with all available pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data. | Cycle 1(21 days) in dose escalation |
| PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) | Determine DA-4505 Cmax | Day 1 and 2 of first 2 cycles (every 21 days) |
| PK parameters for DA-4505 (Area Under the Curve (AUC)) | Determine DA-4505 AUC | Day 1 and 2 of first 2 cycles (every 21 days) |
| PK parameters for DA-4505 (half-life (t1/2)) | Determine DA-4505 half-life (t1/2). | Day 1 and 2 of first 2 cycles (every 21 days) |
| Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) | To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab | approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayun Jang | Contact | +82-2-920-8306 | janycan@donga.co.kr | |
| Hye-yeong Han | Contact | hyhan@donga.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea | |||
| Severance Hospital |
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| DA-4505 + Pembrolizumab |
| Drug |
Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab |
|
| Recruiting |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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