Solid TumorPhase 1NCT04547205
A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors
A Phase 1 study testing AK109 in people with Solid Tumor, run by Akeso at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AK109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2020to 31 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Medicine College, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- AK109
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK109Drug
AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)
| Study group | Role | What they receive |
|---|---|---|
| AK109 | Experimental | Not described Receives: Drug: AK109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first 4 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose of AK109 through 30 days after last dose of AK109
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start6 Jun 2020
- Primary completion24 Mar 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547205
- Sponsor's protocol ID
- AK109-101
- Status last verified
- Feb 2023
- First submitted
- 7 Sep 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36989884
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04547205
- Acronym / sponsor ID
- AK109-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK109 | Experimental | Drug: AK109 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK109AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W) | Drug | AK109 |
Primary outcome
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.
7 secondary outcomes
Adverse events (AEs)
Time frame: 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
Disease control rate (DCR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 36989884Zheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK109 in people with Solid Tumor, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing dose-limiting toxicities (DLTs) (time frame: During the first 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.