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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab
Asan Medical Center
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGProportion 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.
Time frame: Cycle 1(21 days) in dose escalation
PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))
Determine DA-4505 Cmax
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: approximately 12 months
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