Recruiting
Phase 1

AQUA07 & Lorlatinib

Sponsor:

Chugai Pharmaceutical

Code:

NCT07617337

Conditions

ALK Positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AQUA07

Lorlatinib

Study Details

Brief 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.

Conditions

ALK Positive Non-small Cell Lung Cancer

Study ID

NCT07617337

Start date

Jul 24, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PartA: Dose Escalation Part of AQUA07 monotherapy

Dose escalation to determine RP2D/MTD as AQUA07

experimental: PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib

Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib

Interventions

AQUA07

AQUA07 administrated orally

Lorlatinib

Lorlatinib administerd orally

Primary outcome measure

  • Adverse events [PartA,B] [ Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Clinical trials information

only use Emailclinical-trials@chugai-pharm.co.jp

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Chugai Pharmaceutical

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Chugai Pharmaceutical on 2026-09-18.