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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PartA: Dose Escalation Part of AQUA07 monotherapy | Experimental | Dose escalation to determine RP2D/MTD as AQUA07 |
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| PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib | Experimental | Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUA07 | Drug | AQUA07 administrated orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events [PartA,B] | Incidence, nature and severity of adverse events | 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 | 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 | From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of AQUA07 [PartA,B] | To determine the Cmax of AQUA07 | 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials information | Contact | only use Email | clinical-trials@chugai-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Phamaceutical Co.Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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| Lorlatinib |
| Drug |
Lorlatinib administerd orally |
|
To determine the Cavg of AQUA07 |
| 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 | 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 AQUA07 [PartA,B] | To determine the t1/2 of AQUA07 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months) |