Clinical Trial 24214

• Overview

  Study 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

  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.

  Objective:

  Primary Objectives *To evaluate the safety and tolerability of AQUA07 when administered as a single agent *To estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended dose (RD) of AQUA07 when administered as a single agent *To evaluate the safety and tolerability of AQUA07 when administered in combination with lorlatinib *To estimate the MTD or MAD and RD of AQUA07 when administered in combination with lorlatinib Secondary Objectives *To characterize the pharmacokinetic (PK) profile of AQUA07 in plasma when administered as a single agent *To evaluate the preliminary clinical efficacy of AQUA07 when administered as a single agent *To characterize the PK profile of AQUA07 in plasma when administered as a single agent and in combination with lorlatinib *To characterize PK profile of lorlatinib in plasma when administered in combination with AQUA07 *To evaluate the preliminary clinical efficacy of AQUA07 when administered in combination with lorlatinib

• Treatments

  Therapies:

  ATP-competitive ALK tyrosine kinase inhibitors (TKIs); Novel allosteric (ALK) inhibitor

  Medications:

  AQUA07 (); lorlatinib ()

• Inclusion Criteria

  Key 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

  Key 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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.