AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChugai Pharmaceutical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AQUA07
DrugAQUA07 administrated orally
Lorlatinib
DrugLorlatinib administerd orally
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: PartA: Dose Escalation Part of AQUA07 monotherapyExperimental treatment 1 intervention
Group B: PartB: Dose Escalation Part of AQUA07 combotherapty with LorlatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events [PartA,B]
Incidence, nature and severity of adverse events
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months)2
Dose-Limiting Toxicities (DLTs) [PartA,B]
Incidence and nature of DLTs
Time frame
From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)3
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and Recommendation Dose (RD) Determination [PartA,B]
Proportion of patients with course 1 DLT in each cohort
Time frame
From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)Secondary outcomes
1
Maximum plasma concentration (Cmax) of AQUA07 [PartA,B]
To determine the Cmax of AQUA07
Time frame
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)2
Average plasma concentration (Cavg) of AQUA07 [PartA,B]
To determine the Cavg of AQUA07
Time frame
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)3
Time of maximum concentration (Tmax) of AQUA07 [PartA,B]
To determine the Tmax of AQUA07
Time frame
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)4
Elimination half-life (t1/2) of AQUA07 [PartA,B]
To determine the t1/2 of AQUA07
Time frame
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)Sponsors and contacts
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Source ClinicalTrials.gov