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This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANS03 monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANS03 | Drug | ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor). |
|
| 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 ANS03 |
| 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 ANS03 |
| 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 ANS03 to end of DLT period (approximately 30 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 ANS03 |
| 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 ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1) | From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
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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 |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10022 | United States | |
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| 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 ANS03 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 ANS03 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 ANS03 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 ANS03 up until the date of death due to any cause (approximately 2 years) |
| Pharmacokinetics of ANS03: Plasma PK concentrations | Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead | From date of first dose up until 28 days post last dose |
| Pharmacokinetics of ANS03: Area under the concentration time curve (AUC) | Measurement of PK parameters: Area under the concentration time curve (AUC) | From date of first dose up until 28 days post last dose |
| Pharmacokinetics of ANS03: 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 28 days post last dose |
| Pharmacokinetics of ANS03: 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) | Frame: From date of first dose up until 28 days post last dose |
| Pharmacokinetics of ANS03: 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 28 days post last dose |
| Pharmacokinetics of ANS03: Half-life | Measurement of PK parameters: Terminal elimination half-life (t 1/2) | From date of first dose up until 28 days post last dose |
| Research Site |
| Recruiting |
| Fuzhou |
| Fujian |
| China |
| Research Site | Recruiting | Guangzhou | Guangdong | China |
| Research Site | Recruiting | Shanghai | Shanghai Municipality | China |
| Research Site | Recruiting | Chengdu | Sichuan | China |