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

NCT07617337 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • ALK Positive Non-small Cell Lung Cancer

Interventions

DRUG

AQUA07

AQUA07 administrated orally

DRUG

Lorlatinib

Lorlatinib administerd orally

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-24
Primary Completion
2030-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617337 on ClinicalTrials.gov