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

NCT07617337 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AQA101CT
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (3)

• Adverse events [PartA,B]

  Incidence, nature and severity of adverse events

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

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

  Incidence and nature of DLTs

  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]

  Proportion of patients with course 1 DLT in each cohort

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

Secondary Outcomes (14)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

Study Arms (2)

PartA: Dose Escalation Part of AQUA07 monotherapy

EXPERIMENTAL

Dose escalation to determine RP2D/MTD as AQUA07

Drug: AQUA07

PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib

EXPERIMENTAL

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

Drug: Lorlatinib

Interventions

AQUA07 DRUG

AQUA07 administrated orally

PartA: Dose Escalation Part of AQUA07 monotherapy

Lorlatinib DRUG

Lorlatinib administerd orally

PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (7)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Kindai University Hospital

Sakai, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 135-8550, Japan

RECRUITING

The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research)

Koto-Ku, Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Interventions

lorlatinib

Study Officials

• Sponsor Chugai Phamaceutical Co.Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Central Study Contacts

Clinical trials information

CONTACT

only use Email; clinical-trials@chugai-pharm.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (6); US (1)