[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638512":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":25,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":25,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":25,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":25},{"fullName":5,"class":6},"Chugai Pharmaceutical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PartA: Dose Escalation Part of AQUA07 monotherapy","EXPERIMENTAL","Dose escalation to determine RP2D\u002FMTD as AQUA07",[13],"Drug: AQUA07",{"label":15,"type":10,"description":16,"interventionNames":17},"PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib","Dose escalation to determine RP2D\u002FMTD of AQUA07 in combination with lorlatinib",[18],"Drug: Lorlatinib",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AQUA07","AQUA07 administrated orally",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Lorlatinib","Lorlatinib administerd orally",[15],[31],{"name":32,"affiliation":33,"role":34},"Sponsor Chugai Phamaceutical Co.Ltd","clinical-trials@chugai-pharm.co.jp","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":33},"Clinical trials information","CONTACT","only use Email",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638512",false,"NCT07617337","AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer","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","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form\n* 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.)\n* Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Ability and willingness to take oral medication(s)\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* 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\n* Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.\n* 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\n* Significant cardiovascular disease\n* Inadequately controlled hypertension","ALL","18 Years",{"count":51,"type":52},102,"ESTIMATED","INTERVENTIONAL",[55],"PHASE1","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.",[58],"ALK Positive Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-05-24",{"date":62,"type":63},"2026-06-01","ACTUAL",{"date":65,"type":52},"2026-07-31",{"date":67,"type":52},"2030-08-31",{"name":5,"class":6}]