Loading
Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 18, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07617337). This is a study registration, not published results. Lead sponsor: Chugai Pharmaceutical. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 102 participants (ESTIMATED). Conditions: ALK Positive Non-small Cell Lung Cancer. Interventions: DRUG: AQUA07; DRUG: Lorlatinib. Primary outcome measures: Adverse events [PartA,B] , From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months); Dose-Limiting Toxicities (DLTs) [PartA,B] , From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days); Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and Recommendation Dose (RD) Determination [PartA,B] , From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days). Brief 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.