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RECRUITING
NCT06293651
PHASE1/PHASE2

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

Sponsor: Dong-A ST Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: an Open-Label, Phase 1/2a, First-in-Human 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2024-04-18

Completion Date

2029-10

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

DRUG

DA-4505

Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D

DRUG

DA-4505 + Pembrolizumab

Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab

Locations (2)

Asan Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea