ALK Positive Non-small Cell Lung CancerPhase 1NCT07617337
AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
A Phase 1 study testing AQUA07 and Lorlatinib in people with ALK Positive Non-small Cell Lung Cancer, run by Chugai Pharmaceutical at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK Positive Non-small Cell Lung Cancer
- What is being tested?
- AQUA07 and Lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Jul 2026to 31 Aug 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Japan6 sites, 6 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 135-8550
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research)
Koto-Ku, Tokyo, 135-8550
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official 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
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
- Being tested
- AQUA07, Lorlatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUA07Drug
AQUA07 administrated orally
LorlatinibDrug
Lorlatinib administerd orally
| Study group | Role | What they receive |
|---|---|---|
| PartA: Dose Escalation Part of AQUA07 monotherapy | Experimental | Dose escalation to determine RP2D/MTD as AQUA07 Receives: Drug: AQUA07 |
| PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib | Experimental | Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events [PartA,B]
Incidence, nature and severity of adverse events
Measured: 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
Measured: 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
Measured: 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]
To determine the Cmax of AQUA07
Measured: 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]
To determine the Cavg of AQUA07
Measured: 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]
To determine the Tmax of AQUA07
Measured: 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]
To determine the t1/2 of AQUA07
Measured: 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]
To determine the AUC of AQUA07
Measured: 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)
Maximum plasma concentration (Cmax) of Lorlatinib [PartB] Maximum plasma concentration (Cmax) of Lorlatinib [PartB]
To determine the Cmax of Lorlatinib
Measured: 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 Lorlatinib [PartB]
To determine the Cavg of Lorlatinib
Measured: 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 Lorlatinib [PartB]
To determine the Tmax of Lorlatinib
Measured: 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 Lorlatinib [PartB]
To determine the t1/2 of Lorlatinib
Measured: 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 Lorlatinib [PartB]
To determine the AUC of Lorlatinib
Measured: 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)
Objective response related to preliminary clinical efficacy [PartA,B]
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
Measured: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Duration of response (DoR) related to preliminary clinical efficacy [PartA,B]
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
Measured: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Disease control related to preliminary clinical efficacy [PartA,B]
Disease control, defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 as determined by the Investigator
Measured: 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) related to preliminary clinical efficacy [PartA,B]
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
Measured: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start24 Jul 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Phamaceutical Co.Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617337
- Sponsor's protocol ID
- AQA101CT
- Status last verified
- Sep 2026
- First submitted
- 14 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).