AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer

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.

Trial Details

NCT ID
NCT07617337
Phase
PHASE1
Sponsor
Chugai Pharmaceutical
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • AQUA07
  • Lorlatinib
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327
  • Nagoya, Aichi-ken, Japan|35.18147,136.90641
  • Kashiwa, Chiba, Japan|35.86224,139.97732
  • Sakai, Osaka, Japan|34.58216,135.46653
  • Nagaizumi-cho, Shizuoka, Japan

Key Eligibility 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-TK…
  • Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who…
  • Measurable disease per RECIST v1.1

For full eligibility, visit ClinicalTrials.gov.

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