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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 18, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Chugai Pharmaceutical
- Interventions being studied
- Drug: AQUA07; Drug: Lorlatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Aichi Cancer Center HospitalNagoya, Aichi-ken
- National Cancer Center Hospital EastKashiwa, Chiba
- Kindai University HospitalSakai, Osaka
- Shizuoka Cancer CenterNagaizumi-cho, Shizuoka
- National Cancer Center HospitalChuo-ku, Tokyo
- The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research)Koto-Ku, Tokyo
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2026. Always confirm current availability with the study team.