AQUA07 in ALK-positive NSCLC (phase 1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multicenter phase 1 study evaluating AQUA07 as a single agent and in combination with lorlatinib in adults with ALK-positive NSCLC. It aims to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity. Participants must have measurable disease, an ECOG performance status of 0 or 1, and prior ALK-TKI exposure. The study is sponsored by Chugai Pharmaceutical with sites in the US and Japan. Enrollment will consider dose-escalation and potential expansion cohorts depending on safety signals.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Aichi Cancer Center Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa, Chiba, Japan Recruiting
• Kindai University Hospital
  Sakai, Osaka, Japan Recruiting
• Shizuoka Cancer Center
  Nagaizumi-cho, Shizuoka, Japan Recruiting
• National Cancer Center Hospital
  Chuo-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Clinical trials information
• Email: clinical-trials@chugai-pharm.co.jp
• Phone: only use Email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NXP900 with Lorlatinib in ALK-positive NSCLC

  This study tests whether adding NXP900 to lorlatinib helps people with ALK-positive non-small cell lung cancer who have already received prior therapy.

  Recruiting Phase 1 Nuvectis Pharma, Inc. · Fairfax, Virginia · NCT07784959

• TRI-611 for ALK-positive non-small cell lung cancer (Phase 1/2)

  This trial will test TRI-611 to see if it is safe and can shrink tumors in adults with ALK-positive non-small cell lung cancer, including people with different past ALK treatments.

  Recruiting at 20 sites Phase 1/2 TRIANA Biomedicines, Inc. · San Francisco, California and 19 other locations · NCT07491497

• Observational study of lorlatinib for advanced ALK-positive lung cancer patients

  This study looks at how well lorlatinib works and how safe it is for people with advanced ALK-positive lung cancer who are receiving treatment.

  Recruiting Sichuan Cancer Hospital and Research Institute · Chengdu, Sichuan · NCT06361589

• First-line treatment with lorlatinib for advanced ALK+ lung cancer in China

  This study is testing if lorlatinib can be an effective first treatment for people in China with advanced ALK-positive lung cancer.

  Recruiting Phase 2 Guangdong Association of Clinical Trials · Guangzhou, Guangdong · NCT06092086

• Supportive care model for patients with advanced lung cancer

  This study is testing a new supportive care program for people with advanced lung cancer to see if it helps them feel less stressed and more confident about managing their condition compared to standard care.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT04900935

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.