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

Part of paid clinical trials in Houston, Texas.

Sponsor
Chugai Pharmaceutical
Study ID
NCT07617337
Phase
PHASE1
Status
Recruiting
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Conditions

  • ALK Positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AQUA07 — DRUG
    AQUA07 administrated orally
  • Lorlatinib — DRUG
    Lorlatinib administerd orally

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jul 24, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
102 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PartA: Dose Escalation Part of AQUA07 monotherapy
    Dose escalation to determine RP2D/MTD as AQUA07
  • Experimental: PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib
    Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib

Primary Outcome Measure

Adverse events [PartA,B] [ Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
The University of Texas MD Anderson Cancer Center· Houston, TX

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