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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04047290
Other study ID # AK112-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 20, 2019
Est. completion date August 30, 2024

Study information

Verified date October 2022
Source Akeso
Contact Baiyong Li
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK112
AK112 is a PD1/VEGF bispecific antibody.

Locations

Country Name City State
Australia Border Medical Oncology Albury New South Wales
Australia Monash Health Clayton Victoria
Australia Adelaide Cancer Centre Kurralta Park South Australia
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Scientia Clinical Research Ltd Randwick New South Wales
Australia ICON Cancer Foundation South Brisbane Queensland
Australia Blacktown Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Akesobio Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and nature of participants with adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. From time ICF is signed until 90 days after last dose of AK112
Primary Number of participants with DLTs DLTs will be assessed during the 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, intercurrent illness, or concomitant medications that occurs within the first cycle (4 weeks) of treatment. During the first four weeks of treatment with AK112
Secondary Objective response rate (ORR) The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. Up to 2 years
Secondary Disease control rate (DCR) The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD at 16 and 24 weeks respectively) based on RECIST Version 1.1. Up to 2 years
Secondary Progression-free survival (PFS) Progression-free survival is defined as the time from the start of treatment with AK112 until the first documentation of disease progression or death due to any cause, whichever occurs first. Up to 2 years
Secondary Overall survival (OS) Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause. Up to 2 years
Secondary Area under the curve (AUC) of AK112 for assessment of pharmacokinetics The endpoints for assessment of PK of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration. From first dose of AK112 through 90 days after last dose of AK112
Secondary Maximum observed concentration (Cmax) and Minimum observed concentration (Cmin) of AK112 The endpoints for assessment of PK of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration. From first dose of AK112 through 90 days after last dose of AK112
Secondary Number of subjects who develop detectable anti-drug antibodies (ADAs) The immunogenicity of AK112 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). From first dose of AK112 through 90 days after last dose of AK112
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