NCT07617337招募中1 期
A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 8
研究概览
简要总结
This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form
- •Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)
- •Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who have experienced disease progression during or following their most recent systemic therapy or have discontinued the therapy due to unacceptable toxicity
- •Measurable disease per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Ability and willingness to take oral medication(s)
- •Adequate organ function and bone marrow reserve
排除标准
- •Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy
- •Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.
- •Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease
- •Significant cardiovascular disease
- •Inadequately controlled hypertension
- •(Part B only) Patients with prior lorlatinib treatment who experienced serious lorlatinib-related toxicities, or who experienced toxicities considered inappropriate for study participation at the discretion of the Investigator
研究组 & 干预措施
PartA: Dose Escalation Part of AQUA07 monotherapy
Experimental
Dose escalation to determine RP2D/MTD as AQUA07
干预措施: AQUA07 (Drug)
PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib
Experimental
Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib
干预措施: Lorlatinib (Drug)
研究者
研究点 (8)
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