Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Akeso

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: AK109 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: AK109 Drug: AK109
AK109, 2、4、8、12mg/kg, IV, every 2 weeks (Q2W)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Xiaoping Jin, PhD +86 (0760) 8987 3999 clinicaltrials@akesobio.com

Locations
Layout table for location information
China, Zhejiang
The First Affiliated Hospital of Medicine College, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Nong Xu, Master    +86 (0571) 8723 5896    xunongclinictrial@126.com   
Sponsors and Collaborators
Akeso
Layout table for additonal information
Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT04547205    
Other Study ID Numbers: AK109-101
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms