Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK Positive Non-small Cell Lung Cancer | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AQUA07 | Drug | — | UNRESOLVED |
| Lorlatinib | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PartA: Dose Escalation Part of AQUA07 monotherapy
- description
- Dose escalation to determine RP2D/MTD as AQUA07
- interventionNames
- Drug: AQUA07
- type
- EXPERIMENTAL
- label
- PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib
- description
- Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib
- interventionNames
- Drug: Lorlatinib
Primary outcomes (3)
- measure
- Adverse events [PartA,B]
- timeFrame
- From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available