Study of SGR-1505 in Mature B-Cell Neoplasms

Официальное название

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies

Обзор

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.

Подробное описание

This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Вмешательства

• Препарат SGR-1505
  SGR-1505 will be administered orally.

Первичные конечные точки

• Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. [Срок оценки: Throughout the study, up to 2 years.]
• Nature and number of incidences of dose limiting toxicity (DLT). [Срок оценки: The first 21 days.]

Вторичные конечные точки (6)

• SGR-1505 Maximal Plasma Concentration (Cmax) [Срок оценки: Through study completion, up to 2 years.]
• SGR-1505 Time to Maximal Plasma Concentration (tmax) [Срок оценки: Through study completion, up to 2 years.]
• SGR-1505 Area Under the Concentration Versus Time Curve (AUC) [Срок оценки: Through study completion, up to 2 years.]
• Objective Response Rate (ORR) [Срок оценки: Throughout the study, up to 2 years.]
• Duration of Response (DOR) [Срок оценки: Throughout the study, up to 2 years.]
• Disease Control Rate [Срок оценки: Throughout the study, up to 2 years.]

Критерии участия

Критерии включения

• Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
• Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.

Критерии исключения

• The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
• Subject has previous invasive malignancy in the last 2 years.
• Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
• Subject has symptomatic or active CNS involvement of disease.
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.

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

США · 16 центров

• Banner Health - MD Anderson Cancer Center — Gilbert
• Christiana Care Hospital - Helen F Graham Cancer Center — Newark
• Napa Research — Pompano Beach
• Beth Israel Deaconess Medical Center — Boston
• Regional Cancer Care Associates — Hackensack
• Roswell Park Comprehensive Cancer Center — Buffalo
• Weill Cornell — New York
• Montefiore Medical Center — The Bronx
• … и ещё 8 центров

Испания · 6 центров

• Institut Catala d'Oncologia - L'Hospitalet — Barcelona
• Hospital Universitario Quironsalud Madrid — Madrid
• START Madrid - CIOCC — Madrid
• START Madrid - Hospital Fundacion Jimenez Diaz — Madrid
• Clinica Universidad de Navarra - Pamplona — Pamplona
• Hospital Clinico Universitario de Salamanca — Salamanca

Италия · 5 центров

• Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS A — Alessandria
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• IRCCS Ospedale San Raffaele — Milan
• AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette — Torino
• Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma — Verona

Польша · 3 центра

• Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz — Gdansk
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodz — Lodz
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie — Warsaw

Франция · 2 центра

• AP-HP Hôpital Henri-Mondor — Créteil
• Institut Gustave Roussy — Villejuif

Румыния · 2 центра

• ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti — Bucharest
• ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca — Cluj-Napoca

Moldova · 1 центр

• Institute of Oncology, ARENSIA Exploratory Medicine — Chisinau

Украина · 1 центр

• ARENSIA Research Clinic at Harmony Health Clinic — Kyiv

Идентификаторы

NCT: NCT05544019 · SGR-1505-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗