- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547205
A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors
February 21, 2023 updated by: Akeso
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The First Affiliated Hospital of Medicine College, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have signed written informed consent form voluntarily.
- Histologically or cytologically documented advanced solid tumor that is refractory/relapsed/intolerant to standard therapies, or for which no effective standard therapy is available, or subject refuses standard therapy.
- Have radiologically measurable disease based on RECIST 1.1
- ECOG of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Adequate organ function.
- Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
Exclusion Criteria:
- have been diagnosed other advanced tumors within 2 years before the first use of the study drug, except for the cured localized tumors.
- with active central nervous system metastasis, cancerous meningitis, or spinal cord compression.
- Prior use of any anti-VEGF or anti-VEGFR antibodies.
- Receipt of anti-tumor treatment, other study drug, major surgery, or serious infection within 4 weeks prior to C1D1 (Cycle 1 Day1, the first dose of study drug).
- Have received central venous catheterization within 7 days prior to C1D1.
- Severe or uncontrolled cardiovascular and cerebrovascular diseases.
- Uncontrolled hypertension.
- have a high risk of bleeding.
- Uncontrolled gastrointestinal diseases.
- Uncontrolled pleural/pericardial or peritoneal effusion.
- Have occurred any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 monthsprior to C1D1.
- With cirrhosis of Child-Pugh B or C.
- Active or unstable viral hepatitis; or active tuberculosis.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- received live vaccines prior 30 days within the first dose.
- take apart in other clinical studies at the same time.
- known to be allergic to any component of AK109, other monoclonal antibodies or any therapeutic protein.
- mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.
- Any treatment risk or condition that interferes with the study by the investigator judged.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AK109
|
AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During the first 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the time of informed consent signed through to 60 days after last dose of AK109
|
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.
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Up to 2 years
|
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.
|
Up to 2 years
|
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.
|
Up to 2 years
|
Overall survival (OS)
Time Frame: Up to 2 years
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OS is defined as the time from the start of treatment with AK109 until death due to any cause.
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Up to 2 years
|
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.
|
From first dose of AK109 through 30 days after last dose of AK109
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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.
|
From first dose of AK109 through 30 days after last dose of AK109
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2020
Primary Completion (Actual)
March 24, 2021
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK109-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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