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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Chugai Pharmaceutical • ClinicalTrials.gov ID: NCT07617337

Registry updated: 2026-09-18
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Description

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.

Interventions

  • AQUA07 (Drug)
    AQUA07 administrated orally
  • Lorlatinib (Drug)
    Lorlatinib administerd orally

Eligibility criteria

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

Conditions

ALK Positive Non-small Cell Lung Cancer

Locations

  • The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
  • National Cancer Center Hospital East — Kashiwa, Chiba, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record