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NCT Number: NCT07617337

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.

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Key information

Conditions

ALK Positive Non-small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

AQUA07

Drug

AQUA07 administrated orally

Lorlatinib

Drug

Lorlatinib administerd orally

Primary outcomes

  1. Adverse events [PartA,B]

    Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months)

    Incidence, nature and severity of adverse events

  2. Dose-Limiting Toxicities (DLTs) [PartA,B]

    Time frame: From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)

    Incidence and nature of DLTs

  3. Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and Recommendation Dose (RD) Determination [PartA,B]

    Time frame: From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)

    Proportion of patients with course 1 DLT in each cohort

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of AQUA07 [PartA,B]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Cmax of AQUA07

  2. Average plasma concentration (Cavg) of AQUA07 [PartA,B]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Cavg of AQUA07

  3. Time of maximum concentration (Tmax) of AQUA07 [PartA,B]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Tmax of AQUA07

  4. Elimination half-life (t1/2) of AQUA07 [PartA,B]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the t1/2 of AQUA07

  5. Area under the plasma concentration-time curve (AUC) of AQUA07 [PartA,B]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the AUC of AQUA07

  6. Maximum plasma concentration (Cmax) of Lorlatinib [PartB] Maximum plasma concentration (Cmax) of Lorlatinib [PartB]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Cmax of Lorlatinib

  7. Average plasma concentration (Cavg) of Lorlatinib [PartB]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Cavg of Lorlatinib

  8. Time of maximum concentration (Tmax) of Lorlatinib [PartB]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the Tmax of Lorlatinib

  9. Elimination half-life (t1/2) of Lorlatinib [PartB]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the t1/2 of Lorlatinib

  10. Area under the plasma concentration-time curve (AUC) of Lorlatinib [PartB]

    Time frame: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    To determine the AUC of Lorlatinib

  11. Objective response related to preliminary clinical efficacy [PartA,B]

    Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    Objective response, defined as a confirmed complete response (CR) or partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by the Investigator

  12. Duration of response (DoR) related to preliminary clinical efficacy [PartA,B]

    Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    DoR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first

  13. Disease control related to preliminary clinical efficacy [PartA,B]

    Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    Disease control, defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 as determined by the Investigator

  14. Progression-Free Survival (PFS) related to preliminary clinical efficacy [PartA,B]

    Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

    Progression-free survival (PFS), defined as the time from the first day of study treatment to the first occurrence of disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical trials information

CONTACT

[email protected]

only use Email

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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