A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DCC-3009 Module A
Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.
干预措施: DCC-3009 (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
时间窗: Cycle 1 (28 Days)
DLTs assessed for each dose level.
Objective Response Rate (ORR) (Part 2 Expansion)
时间窗: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
次要结局
- Objective Response Rate (ORR) (Part 1 Escalation)(Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months))
- Progression-Free Survival (PFS)(Initiation of Treatment to PD or Death (Estimated up to 24 months))
- Duration of Response (DOR)(First Recorded CR or PR until PD or Death (Estimated up to 24 months))
- Overall Survival (OS)(Initiation of Treatment to Death from Any Cause (Estimated up to 24 months))
- Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)(Estimated up to 24 months)