臨床研究等提出・公開システム

A PHASE I, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND COHORT EXPANSION STUDY OF AQUA07 MONOTHERAPY AND COMBINATION THERAPY IN PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER

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

Agajanov, Tamara

Chugai Pharmaceutical USA

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

July. 31, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER

AQUA07:Oral
Lorlatinib:Oral

safety
To evaluate the safety and tolerability based on NCI CTCAE v5.0, clinical laboratory test results, ECGs, Vital signs and DLT criteria.

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.

+81-3-3520-0111

June. 19, 2026

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

United States of America