2024-514266-39-00招募中2 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 25
- 主要终点
- Phase 1 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters
研究概览
简要总结
Phase 1 - To evaluate the overall safety and tolerability of NVL-655 Phase 1 - To determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK-positive solid tumors Phase 2 - To evaluate the efficacy of NVL-655 at the RP2D in patients with advanced ALK-positive NSCLC, including those with ALK resistance mutations, and other solid tumors
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Phase 2 Cohort 2f only: Age ≥ 12 years and weight > 40 kg.
- •Disease criteria: Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
- •Disease criteria: Cohorts 2a, 2b, 2c, 2d, and 2e: Histologically or cytologically confirmed locally advanced or metastatic ALK rearrangement or activating ALK mutation
- •Disease criteria: Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2e) with a documented ALK rearrangement or activating ALK mutation.
- •Prior anticancer treatment: Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1
- •Prior anticancer treatment: Phase 2: Must have measurable disease, defined as ≥1 radiologically measurable target lesion according to RECIST 1.1
- •Pre-treatment tumor tissue
- •Please refer to the protocol for further criteria
排除标准
- •Patient’s cancer has a known oncogenic driver alteration other than ALK
- •Known allergy/hypersensitivity to excipients of NVL-655
- •Major surgery within 4 weeks of first dose of study drug
- •Ongoing or recent anticancer therapy
- •Ongoing or recent radiation therapy
- •Please refer to the protocol for further criteria
结局指标
主要结局
Phase 1 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters
Phase 1 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters
Phase 1 - RP2D and, if applicable, the MTD
Phase 1 - RP2D and, if applicable, the MTD
Phase 2 - ORR according to RECIST 1.1
Phase 2 - ORR according to RECIST 1.1
次要结局
- Phase 1 - PK parameters of NVL-655
- Phase 1 - ORR according to RECIST 1.1 assessment
- Phase 2 - DOR
- Phase 2 - IC-ORR
- Phase 2 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters
- Phase 2 - PK parameters of NVL-655
- Phase 2 - Changes in PROs
研究者
Medical
Scientific
Nuvalent Inc.
研究点 (25)
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