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

Phase 1Not Yet RecruitingNCT07617337

Chugai Pharmaceutical102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

ALK Positive Non-small Cell Lung Cancer

Interventions

AQUA07DRUG

AQUA07 administrated orally

LorlatinibDRUG

Lorlatinib administerd orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * 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: * 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

Outcomes

Primary Outcomes

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)

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)

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

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)

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)

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)

Central Contacts

Clinical trials information

CONTACT

only use Email clinical-trials@chugai-pharm.co.jp

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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)

Area under the plasma concentration-time curve (AUC) of AQUA07 [PartA,B]

To determine the AUC 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)

Maximum plasma concentration (Cmax) of Lorlatinib [PartB] Maximum plasma concentration (Cmax) of Lorlatinib [PartB]

To determine the Cmax of Lorlatinib

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)

Average plasma concentration (Cavg) of Lorlatinib [PartB]

To determine the Cavg of Lorlatinib

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)

Time of maximum concentration (Tmax) of Lorlatinib [PartB]

To determine the Tmax of Lorlatinib

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)

Elimination half-life (t1/2) of Lorlatinib [PartB]

To determine the t1/2 of Lorlatinib

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)

Area under the plasma concentration-time curve (AUC) of Lorlatinib [PartB]

To determine the AUC of Lorlatinib

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)

Objective response related to preliminary clinical efficacy [PartA,B]

Objective response, defined as a confirmed complete response (CR) or partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by the Investigator

Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

Duration of response (DoR) related to preliminary clinical efficacy [PartA,B]

DoR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first

Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

Disease control related to preliminary clinical efficacy [PartA,B]

Disease control, defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 as determined by the Investigator

Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

Progression-Free Survival (PFS) related to preliminary clinical efficacy [PartA,B]

Progression-free survival (PFS), defined as the time from the first day of study treatment to the first occurrence of disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first

Time frame: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)