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RECRUITING
NCT07215637
PHASE1

Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

Sponsor: Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.

Official title: A Multicenter, Open-label, Dose-escalation, Phase Ia/Ib Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-16

Completion Date

2027-09

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

CKD-512

Orally administered BID

COMBINATION_PRODUCT

Pembrolizumab

Intravenous (IV) Infusion

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea