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This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANS02 | Experimental | ANS02 capsules, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANS02 | Drug | 4 dose levels would be explored during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Number of patients with adverse events by system organ class and preferred term | From the time of first dose to 28 days post last dose of ANS02 |
| Incidence of Serious Adverse Events (SAEs) | Number of patients with serious adverse events by system organ class and preferred term | From time of first dose to 28 days post last dose of ANS02 |
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol | From time of first dose of ANS02 to end of DLT period (approximately 28 days) |
| Incidence of baseline laboratory finding, ECG and vital signs changes | Measured by laboratory and vital sign variables over time including change from baseline | From time of first dose to 28 days post last dose of ANS02 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ANS02: Plasma PK concentrations | Measurement of plasma concentrations of ANS02 | From date of first dose of ANS02 up until 7 days post last dose |
| Pharmacokinetics of ANS02: Area under the concentration time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avistone Clinical Study Information Center | Contact | 8610 84148921 | information.center@avistonebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Fairfax | Virginia | 22031 | United States | |
| Research Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Measurement of PK parameters: Area under the concentration time curve (AUC)
| From date of first dose of ANS2 up until 7 days post last dose |
| Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max) | Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) | From date of first dose up until 7 days post last dose |
| Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max) | Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) | From date of first dose up until 7 days post last dose |
| Pharmacokinetics of ANS02: Clearance | Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance) | From date of first dose up until 7 days post last dose |
| Pharmacokinetics of ANS02: Half-life | Measurement of PK parameters: Terminal elimination half-life (t 1/2) | From date of first dose up until 7 days post last dose |
| Proportion of patients with radiological response (ORR) | Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 | From date of first dose of ANS02 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years) |
| Duration of Response (DoR) | The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression | From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Disease Control Rate (DCR) | The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) | From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Progression free Survival (PFS) | The time from first dose until RECIST 1.1 defined disease progression or death due to any cause | From date of first dose of ANS02 up until date of progression or death due to any cause (approximately 2 years)] |
| Overall Survival (OS) | The time from the date of the first dose of study treatment until death due to any cause | From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years) |
| Not yet recruiting |
| Guangzhou |
| Guangdong |
| China |
| Research Site | Recruiting | Harbin | Heilongjiang | China |
| Research Site | Not yet recruiting | Zhengzhou | Henan | China |
| Study Site | Not yet recruiting | Chengdu | Sichuan | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |