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RecruitingPhase 1NCT07617337

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

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

Sponsor

Chugai Pharmaceutical

Enrollment

102 participants

Start Date

Jul 24, 2026

Study Type

INTERVENTIONAL

Conditions

ALK-positive Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AQUA07 and a drug called Lorlatinib for people with alk-positive non-small cell lung cancer. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAQUA07

AQUA07 administrated orally

DRUGLorlatinib

Lorlatinib administerd orally

Locations(7)

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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NCT07617337

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