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This is a first in human(FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and anti-tumor activity of AK109, an anti-VEGFR2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK109 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK109 | Drug | AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing dose-limiting toxicities (DLTs) | DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (4 weeks) of treatment. | During the first 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product. Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Medicine College, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36989884 | Derived | Zheng Y, Zhong H, Zhao F, Zhou H, Mao C, Lv W, Yuan M, Qian J, Jiang H, Wang Z, Xiao C, Guo J, Liu T, Liu W, Wang ZM, Li B, Xia M, Xu N. First-in-human, phase I study of AK109, an anti-VEGFR2 antibody in patients with advanced or metastatic solid tumors. ESMO Open. 2023 Apr;8(2):101156. doi: 10.1016/j.esmoop.2023.101156. Epub 2023 Mar 28. |
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| From the time of informed consent signed through to 60 days after last dose of AK109 |
| Objective response rate (ORR) | ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1. | Up to 2 years |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1. | Up to 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the start of treatment with AK109 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) | OS is defined as the time from the start of treatment with AK109 until death due to any cause. | Up to 2 years |
| Observed pharmacokinetics (PK) exposure of AK109 | The endpoints for assessment of PK of AK109 include serum concentrations of AK109 at different timepoints after AK109 administration. | From first dose of AK109 through 30 days after last dose of AK109 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK109 will be assessed by summarizing the number of subjects who develop detectable ADAs. | From first dose of AK109 through 30 days after last dose of AK109 |