A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Официальное название

A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)

Обзор

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Вмешательства

• Препарат DCC-3009
  Administered orally

Первичные конечные точки

• Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) [Срок оценки: Cycle 1 (28 Days)]
• Objective Response Rate (ORR) (Part 2 Expansion) [Срок оценки: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) (Part 1 Escalation) [Срок оценки: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)]
• Duration of Response (DOR) [Срок оценки: First Recorded CR or PR until PD or Death (Estimated up to 24 months)]
• Progression-Free Survival (PFS) [Срок оценки: Initiation of Treatment to PD or Death (Estimated up to 24 months)]
• Overall Survival (OS) [Срок оценки: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)]
• Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) [Срок оценки: Estimated up to 24 months]

Критерии участия

Критерии включения

Module A Part 1 (Escalation):

• Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting
• Have at least 1 measurable lesion as defined by mRECIST, v1.1
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Adequate organ function, bone marrow function, and electrolytes
• All participants agree to comply with the contraception requirements
• Have a life expectancy of more than 3 months

Критерии исключения

• Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
• Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
• Has known active central nervous system (CNS) metastases or an active primary CNS cancer
• History or presence of clinically relevant cardiovascular abnormalities
• Major surgery within 28 days of the first dose of study drug
• Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
• Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
• Known allergy or hypersensitivity to any component of the study drug
• Malabsorption syndrome or other illness that could affect oral absorption
• Any other clinically significant comorbidities

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 · 10 центров

• HonorHealth — Scottsdate
• UC San Diego Moores Cancer Center — La Jolla
• University of Colorado Anschutz Medical Campus — Aurora
• Mayo Clinic Florida — Jacksonville
• University of Miami - Sylvester Comprehensive Cancer Center — Miami
• Dana Farber Cancer Institute — Boston
• START Midwest — Grand Rapids
• Mayo Clinic Rochester — Rochester
• … и ещё 2 центра

Идентификаторы

NCT: NCT06630234 · DCC-3009-01-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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