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

Akeso1 site in 1 country40 target enrollmentJune 6, 2020

ConditionsSolid Tumor

InterventionsAK109

DrugsAK109

Overview

Phase: Phase 1
Intervention: AK109
Conditions: Solid Tumor
Sponsor: Akeso
Enrollment: 40
Locations: 1
Primary Endpoint: Number of subjects experiencing dose-limiting toxicities (DLTs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 6, 2020

End Date

October 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

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
•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 C1D
•Severe or uncontrolled cardiovascular and cerebrovascular diseases.
•Uncontrolled hypertension.
•have a high risk of bleeding.
•Uncontrolled gastrointestinal diseases.
•Uncontrolled pleural/pericardial or peritoneal effusion.

Arms & Interventions

AK109

Intervention: AK109

Outcomes

Primary Outcomes

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 Outcomes

Objective response rate (ORR)(Up to 2 years)
Disease control rate (DCR)(Up to 2 years)
Overall survival (OS)(Up to 2 years)
Adverse events (AEs)(From the time of informed consent signed through to 60 days after last dose of AK109)
Progression-free survival (PFS)(Up to 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK109 through 30 days after last dose of AK109)
Observed pharmacokinetics (PK) exposure of AK109(From first dose of AK109 through 30 days after last dose of AK109)