A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04547205|
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: AK109||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AK109，an Anti-VEGFR2 Monoclonal Antibody in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||June 6, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
AK109, 2、4、8、12mg/kg, IV, every 2 weeks (Q2W)
- Number of subjects experiencing dose-limiting toxicities (DLTs) [ Time Frame: During the first 4 weeks ]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.
- Adverse events (AEs) [ Time Frame: From the time of informed consent signed through to 60 days after last dose of AK109 ]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.
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
- Disease control rate (DCR) [ Time Frame: Up to 2 years ]DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]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.
- Overall survival (OS) [ Time Frame: Up to 2 years ]OS is defined as the time from the start of treatment with AK109 until death due to any cause.
- Observed pharmacokinetics (PK) exposure of AK109 [ Time Frame: From first dose of AK109 through 30 days after last dose of AK109 ]The endpoints for assessment of PK of AK109 include serum concentrations of AK109 at different timepoints after AK109 administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of AK109 through 30 days after last dose of AK109 ]The immunogenicity of AK109 will be assessed by summarizing the number of subjects who develop detectable ADAs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547205
|Contact: Xiaoping Jin, PhD||+86 (0760) 8987 firstname.lastname@example.org|
|The First Affiliated Hospital of Medicine College, Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Contact: Nong Xu, Master +86 (0571) 8723 5896 email@example.com|