AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
Recruiting · NCT07617337 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
AQUA07Lorlatinib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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
Where it is running
5 locations listed.
- Aichi Cancer Center Hospital - Nagoya, Aichi-ken, Japan
- Kindai University Hospital - Sakai, Osaka, Japan
- Shizuoka Cancer Center - Nagaizumi-cho, Shizuoka, Japan
- National Cancer Center Hospital - Chuo-ku, Tokyo, Japan
- The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research) - Koto-Ku, Tokyo, Japan