NIPH Clinical Trials Search

A Phase I Study of AQUA07 in Patients with ALK-Positive Non-Small Cell Lung Cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER
Date of first enrollment	31/07/2026
Target sample size	102
Countries of recruitment	United States of America,Japan
Study type	Interventional
Intervention(s)	AQUA07:Oral Lorlatinib:Oral

Outcome(s)

Primary Outcome	safety To evaluate the safety and tolerability based on NCI CTCAE v5.0, clinical laboratory test results, ECGs, Vital signs and DLT criteria.
Secondary Outcome	efficacy,phamacokinetics To evaluate preliminarry efficacy based on RECIST v1.1. To evaluate PK profile of AQUA07 through assessment of plasma AQUA07 concentration. To evaluate PK profile of AQUA07 when administered in combination with lorlatinib. To evaluate PK profile of lorlatinib when administered in combination with AQUA07.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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