Clinical trial NCT04547205: A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of subjects experiencing dose-limiting toxicities (DLTs)
timeFrame: During the first 4 weeks
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: From the time of informed consent signed through to 60 days after last dose of AK109
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Observed pharmacokinetics (PK) exposure of AK109
timeFrame: From first dose of AK109 through 30 days after last dose of AK109
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of AK109 through 30 days after last dose of AK109
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medicine College, Zhejiang University
state: Zhejiang
Study officials:
References: