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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso

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.