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

Chugai Pharmaceutical

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: ALK Positive Non-small Cell Lung Cancer

Treatments: Drug: AQUA07; Drug: Lorlatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07617337

AQA101CT

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

PartA: Dose Escalation Part of AQUA07 monotherapy

Experimental group

Description:

Dose escalation to determine RP2D/MTD as AQUA07

Treatment:

Drug: AQUA07

PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib

Experimental group

Description:

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

Treatment:

Drug: Lorlatinib