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

NCT ID: NCT04547205

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-06
• Study Completion Date: 2022-10-31

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK109

Group Type: EXPERIMENTAL

AK109

Intervention Type: DRUG

AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)

Interventions

AK109

AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Medicine College, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36989884 (View on PubMed)

Other Identifiers

AK109-101

Identifier Type: -

Identifier Source: org_study_id