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Идёт набор NCT07751991

A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML

Фаза I С лечением AML (Acute Myeloid Leukemia)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CHM-029.
Кому может быть актуально
Состояния в реестре: AML (Acute Myeloid Leukemia). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029 as Monotherapy in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) With NPM1 Mutations, KMT2A or NUP98 Rearrangements

Обзор

The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults. The main questions the study aims to answer are: * What is an appropriate dose of CHM-029? * What side effects may occur with CHM-029? * How does the body process CHM-029? Researchers will evaluate increasing dose levels of CHM-029 to better understand its safety and how the body responds to treatment. Participants will visit the study clinic regularly for safety assessments, blood tests, electrocardiograms (ECGs), and bone marrow evaluations to monitor their health and response to treatment.

Подробное описание

CHM-029-01 is a Phase 1/2, first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of orally administered CHM-029 in adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement.

Вмешательства

  • Препарат CHM-029
    CHM-029 is administered orally.

Первичные конечные точки

  • Number of participants with dose limiting toxicities (DLTs) [Срок оценки: Baseline through Day 28]
  • Number of participants with adverse events (AEs) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Number of participants with adverse events (AEs) by severity [Срок оценки: Baseline through study completion, an average of 3 years]
  • Number of participants with laboratory value abnormalities and/or adverse events (AEs) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Rates of dose modification due to adverse events (AEs) according to NCI CTCAE [Срок оценки: Baseline through study completion, an average of 3 years]
  • Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029 [Срок оценки: Baseline through study completion, an average of 3 years]
Вторичные конечные точки (10)
  • Pharmacokinetics (PK) profile of CHM-029: Plasma concentrations [Срок оценки: Baseline through study completion, an average of 3 years]
  • Pharmacokinetic (PK) profile of CHM-029: Area under the curve [Срок оценки: Baseline through study completion, an average of 3 years]
  • Pharmacokinetic (PK) profile of CHM-029: Time of maximum concentration (Tmax) and half-life (T1/2) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Complete remission and complete remission with partial hematological recovery (CR/CRh) rate [Срок оценки: Baseline to study completion, an average of 3 years]
  • Composite complete remission rate (CRc) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Duration of response (DOR) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Morphological leukemia free state (MLFS) rate [Срок оценки: Baseline through study completion, an average of 3 years]
  • Best response rate [Срок оценки: Baseline through study completion, an average of 3 years]
  • Overall survival (OS) [Срок оценки: Baseline through study completion, an average of 3 years]
  • Event free survival (EFS) [Срок оценки: Baseline through study completion, an average of 3 years]

Критерии участия

Критерии включения

  • 18 years old and above
  • Relapsed or refractory (R/R) acute myeloid leukemia (AML) and has had treatment with any available standard therapies
  • Positive for NPM1 mutation, or KMT2A or NUP98 rearrangements

Критерии исключения

  • White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment
  • Extramedullary only AML
  • Has current complications related to hematopoietic stem cell transplant (HSCT)
  • Other cancers that require treatment
  • Active Hepatitis or HIV infection
  • Moderate hepatic or renal impairment
  • Acute promyelocytic leukemia
  • Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP)
  • Congestive heart failure NYHA Class 3 or 4
  • Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • START Midwest — Grand Rapids

Идентификаторы

NCT: NCT07751991 · CHM-029-01 · 2026-526409-14

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗