SNV1521 in Participants With Advanced Solid Tumors

Официальное название

A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors

Обзор

This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.

Вмешательства

• Препарат SNV1521
  SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
• Препарат DB-1310
  DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
• Препарат Abiraterone
  Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
• Препарат Darolutamide
  Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.

Первичные конечные точки

• Safety of SNV1521 [Срок оценки: From first dose through last dose (up to 13 months)]
• Tolerability of SNV1521 [Срок оценки: DLTs: From first dose through completion of first cycle (28 days)]

Критерии участия

Критерии включения

• Advanced or metastatic solid tumor malignancy
• Evaluable or Measurable disease (RECIST 1.1 Criteria).
• ECOG Performance Status 0 or 1.
• Life expectancy > 3 months

Критерии исключения

• History of other malignancy within the past 2 years
• Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
• Significant cardiovascular disease within 6 months
• Significant gastrointestinal disease
• HIV infection with a CD4+ T-cell count < 200 cells/μL and/or a detectable viral load
• Liver dysfunction

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Smilow Cancer Hospital at Yale New Haven — New Haven
• Thomas Jefferson University — Philadelphia
• Sarah Cannon Research Institute — Nashville
• The University of Texas M.D. Anderson Cancer Center — Houston
• START Center for Cancer Care — West Valley City

Австралия · 5 центров

• Scientia Clinical Research — Randwick
• Princess Alexandra Hospital — Woolloongabba
• Monash Health — Clayton
• The Alfred Hospital — Melbourne
• Linear Clinical Research — Crawley

Бельгия · 4 центра

• The Institut Jules Bordet — Brussels
• University Center for Clinical Research Antwerp (UNICCRA) — Edegem
• AZ Maria Middelares — Ghent
• AZ Groeninge — Kortrijk

Испания · 4 центра

• NEXT Oncology - Barcelona — Barcelona
• Vall d'Hebron University Hospital — Barcelona
• The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchina — Madrid
• NEXT Oncology - Hospital Quironsalud Madrid — Madrid

Франция · 3 центра

• Institut Bergonie — Bordeaux
• UNICANCER - Centre Leon-Berard (CLB) — Lyon
• Gustave Roussy — Villejuif

Канада · 2 центра

• Arthur J.E. Child Comprehensive Cancer Centre — Calgary
• Princess Margaret Hospital — Toronto

Италия · 2 центра

• Istituto Clinico Humanitas — Milan
• Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) — Milan

Идентификаторы

NCT: NCT06220864 · SNV1521-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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