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This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANS014004 Monotherapy | Experimental | Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004. Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANS014004 | Drug | Varying doses of ANS014004 |
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| 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 ANS014004 |
| 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 ANS014004 |
| 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 ANS014004 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 | From time of first dose to 28 days post last dose of ANS014004 |
| 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 ANS014004 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 ANS014004 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 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Beijing Avistone Biotechnology Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States | |
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| Duration of Response (DoR) | The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) | From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Disease Control Rate (DCR) | From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression | From date of first dose of ANS014004 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 | rom date of first dose of ANS014004 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 ANS014004 up until the date of death due to any cause (approximately 2 years) |
| Pharmacokinetics of ANS014004: Plasma PK concentrations | Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead | From date of first dose up until 28 days post last dose |
| Pharmacokinetics of ANS014004: 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 ANS014004: 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 ANS014004: 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 28 days post last dose |
| Pharmacokinetics of ANS014004: 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 ANS014004: 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 |
| Sarah Cannon Research Institute |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Advent Health | Recruiting | Orlando | Florida | 32804 | United States |
| Henry Ford Health Cancer | Recruiting | Detroit | Michigan | 48202 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10003 | United States |
| The University of Texas - MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| NEXT Oncology, Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98195 | United States |
| BC Cancer Vancouver Centre | Recruiting | Vancouver | British Columbia | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | Canada |
| Beijing Chest Hospital | Not yet recruiting | Beijing | Beijing Municipality | 101149 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150010 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
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| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|