AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
Sponsored by Chugai Pharmaceutical
About this study
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.
Where this study is enrolling
- Call 877-632-6789
The University of Texas MD Anderson Cancer Center
Houston, Texas
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Who can participate
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, 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
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
- ✕(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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
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Trial data sourced from ClinicalTrials.gov.