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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат DA-4505
  Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
• Препарат DA-4505 + Pembrolizumab
  Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab

Первичные конечные точки

• Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria [Срок оценки: Cycle 1(21 days) in dose escalation]
• PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) [Срок оценки: Day 1 and 2 of first 2 cycles (every 21 days)]
• PK parameters for DA-4505 (Area Under the Curve (AUC)) [Срок оценки: Day 1 and 2 of first 2 cycles (every 21 days)]
• PK parameters for DA-4505 (half-life (t1/2)) [Срок оценки: 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) [Срок оценки: approximately 12 months]

Критерии участия

Критерии включения

• Aged 18 and older.
• Capable of giving signed informed consent.
• Diagnosed with particular disease characteristics.
• Expected survival ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• A female patient is eligible to participate if she is not pregnant or breastfeeding.
• A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.
• Have measurable disease by revised RECIST v1.1 criteria.

Критерии исключения

• Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
• Current enrollment or past participation in another clinical trial.
• Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.
• Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.
• Autologous transplantation within 60 days.
• Prior allogeneic transplantation.
• Major surgery within 30 days, or unresolved complications after a major or minor surgery.
• History of or currently active cardiovascular disease.
• Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
• History of other malignancy.

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 · 2 центра

• Asan Medical Center — Seoul
• Severance Hospital — Seoul

Идентификаторы

NCT: NCT06293651 · DA4505_AMST_I/IIa

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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