Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas

Официальное название

Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas

Обзор

The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are: What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)? Participants will: Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight

Подробное описание

This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.

Вмешательства

• Препарат BTM-3566
  Oral Solution

Первичные конечные точки

• Adverse Event and dose-limiting toxicity event rates [Срок оценки: 24 months]

Критерии участия

Критерии включения

• must be age ≥18 years
• must have a diagnosis of relapsed or refractory mature B cell lymphoma
• must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
• must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• must have a predicted life expectancy of ≥3 months
• must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566

Критерии исключения

• has primary CNS lymphoma
• has ongoing toxicities from prior anti-cancer treatment > Grade 1
• has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
• has received any anti-cancer therapy (including radiation of curative intent) <28 days prior to administration of BTM-3566
• has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
• is pregnant or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Levine Cancer Institute, Atrium Health — Charlotte
• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06792734 · BTM-3566-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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