A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors

Akeso

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: AK109

Study type

Interventional

Funder types

Industry

Identifiers

NCT04547205

AK109-101

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.