ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

Официальное название

A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

Обзор

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.

Подробное описание

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.

Вмешательства

• Препарат ELVN-001
  Orally once or twice daily

Первичные конечные точки

• Part 1: Incidence of dose limiting toxicities [Срок оценки: 28 days]
• Part 1: Incidence of adverse events (AEs) [Срок оценки: Up to 28 days]
• Part 1: Incidence of clinically significant laboratory abnormalities [Срок оценки: Up to 28 days]
• Part 1: Incidence of clinically significant ECG abnormalities [Срок оценки: Up to 28 days]
• Part 2: Incidence of adverse events [Срок оценки: Up to 3 years]
• Part 2: Incidence of clinically significant laboratory abnormalities [Срок оценки: Up to 3 years]
• Part 2: Incidence of clinically significant ECG abnormalities [Срок оценки: Up to 3 years]

Вторичные конечные точки (7)

• Area under the curve [Срок оценки: 6 months]
• Maximum concentration [Срок оценки: 6 months]
• Time of maximum concentration [Срок оценки: 6 months]
• Minimum concentration [Срок оценки: 6 months]
• Molecular response (MR) [Срок оценки: Up to 3 years]
• Duration of Molecular Response [Срок оценки: Up to 3 years]
• Complete Hematologic Response (CHR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
• ECOG performance status of 0 to 2.
• The patient was born in Japan and both parents and grandparents are Japanese.
• Adequate hematologic, hepatic and renal function.
• Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.

Критерии исключения

• Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
• History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
• QTc >470 ms.

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

Япония · 4 центра

• Akita University Hospital — Akita
• Aiiku Hospital — Sapporo
• The University of Osaka Hospital — Suita-shi
• Tokyo Medical University Hospital — Shinjuku-ku

Идентификаторы

NCT: NCT06787144 · ELVN-001-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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