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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат CKD-512
  Orally administered BID
• Комбинированный продукт Pembrolizumab
  Intravenous (IV) Infusion

Первичные конечные точки

• Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED) [Срок оценки: Up to 2 years]
• Part B: Recommended dose for expansion (RDE) [Срок оценки: Up to 2 years]

Вторичные конечные точки (9)

• Safety and tolerability [Срок оценки: Up to 2 years]
• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Up to 2 years]
• Cmax at steady state (Cmax_ss) [Срок оценки: Up to 2 years]
• Area Under the Curve to the last measurable concentration (AUClast) [Срок оценки: Up to 2 years]
• Area Under the Curve over the dosing interval tau (AUCtau) [Срок оценки: Up to 2 years]
• Overall Response Rate (ORR) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Histologically confirmed advanced or metastatic solid tumors.
• Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.
• Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Suitable venous access for the study-required blood sampling, including PK and PD sampling.
• Adequate clinical laboratory values and other measures

Критерии исключения

• Active disease involvement of the central nervous system.
• Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Systemic anticancer treatment within the protocol-specified period prior to the first dose.
• History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy
• Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.
• Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Severance Hospital, Yonsei University Health System — Seoul

Идентификаторы

NCT: NCT07215637 · A150_01ST2410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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