Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies

Официальное название

A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies

Обзор

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed/refractory B-cell malignancies.

Вмешательства

• Препарат EXS73565
  EXS73565 oral administration

Первичные конечные точки

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to 282 days]
• Number of Participants With Dose-limiting toxicities (DLTs) [Срок оценки: Up to 28 days]

Вторичные конечные точки (9)

• Time to Maximum Concentration (Tmax) of EXS73565-001 [Срок оценки: Up to 253 days]
• Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001 [Срок оценки: Up to 253 days]
• Maximum Concentration (Cmax) of EXS73565-001 [Срок оценки: Up to 253 days]
• Overall Response Rate (ORR) [Срок оценки: Up to 434 days]
• Progression Free Survival [Срок оценки: Up to 434 days]
• Duration of Response [Срок оценки: Up to 434 days]
• Time to Respond [Срок оценки: Up to 434 days]
• Time to Progression [Срок оценки: Up to 434 days]
• Overall Survival [Срок оценки: 12 and 24 months]

Критерии участия

Критерии включения

• Age ≥18 years at the time of signing the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.
• Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy

Критерии исключения

• Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
• Known central nervous system (CNS) malignancy or primary CNS lymphoma.
• Concurrent active or previous malignancy (other than the primary lymphoma/CLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.
• Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.

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

Испания · 4 центра

• Hospital Beata Maria Ana — Madrid
• Hospital Fundación Jiménez Diaz — Madrid
• Hospital Universitario HM Sanchinarro — Madrid
• Clinica Universidad de Navarra — Pamplona

Великобритания · 2 центра

• St James's University Hospital — Leeds
• University Hospitals Plymouth NHS Trust (Derriford Hospital) — Plymouth

Грузия · 1 центр

• LLC ARENSIA Exploratory Medicine — Tbilisi

Moldova · 1 центр

• IMSP Institute of Oncology, ARENSIA Exploratory Medicine — Chisinau

Украина · 1 центр

• Medical Center of LLC ARENSIA Exploratory Medicine — Kyiv

Идентификаторы

NCT: NCT06980116 · EXS73565-001 · 2024-516869-36-00 · 2022-003475-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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