A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04047290|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : January 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Malignant||Drug: AK112||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||151 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Sequential Assignment Initially, a single-subject cohort will be enrolled at the protocol starting dose of AK112 every 2 weeks (Q2W). Dose escalation will proceed to the next main dose level according to the 3+3+3 dose-escalation procedure until the MTD is reached. Dose expansion phase of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose-escalation phase.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||September 20, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||February 28, 2024|
AK112 IV every 2 weeks (q2w) or every 3 weeks (q3w)
AK112 is a PD1/VEGF bispecific antibody.
- Incidence and nature of participants with adverse events (AEs) [ Time Frame: From time ICF is signed until 90 days after last dose of AK112 ]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.
- Number of participants with DLTs [ Time Frame: During the first four weeks of treatment with AK112 ]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.
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
- Disease control rate (DCR) [ Time Frame: Up to 2 years ]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.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]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.
- Overall survival (OS) [ Time Frame: Up to 2 years ]Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause.
- Area under the curve (AUC) of AK112 for assessment of pharmacokinetics [ Time Frame: From first dose of AK112 through 90 days after last dose of AK112 ]The endpoints for assessment of PK of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration.
- Maximum observed concentration (Cmax) and Minimum observed concentration (Cmin) of AK112 [ Time Frame: From first dose of AK112 through 90 days after last dose of AK112 ]The endpoints for assessment of PK of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of AK112 through 90 days after last dose of AK112 ]The immunogenicity of AK112 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047290
|Contact: Kon Yew Kwek, BMBCh, DPhil||+86 (0760) 8987 firstname.lastname@example.org|
|Australia, New South Wales|
|Border Medical Oncology||Completed|
|Albury, New South Wales, Australia|
|Scientia Clinical Research Ltd||Recruiting|
|Randwick, New South Wales, Australia|
|Contact +61 2 9382 5811|
|Principal Investigator: Charlotte Lemech, MBBS|
|Sydney, New South Wales, Australia|
|Contact: Joanna Jackson Joanna.email@example.com|
|Principal Investigator: Adnan Nagrial, MBBS|
|ICON Cancer Foundation||Recruiting|
|South Brisbane, Queensland, Australia|
|Contact +61 3737 4500|
|Principal Investigator: Jermaine Coward, MBBS|
|Australia, South Australia|
|Adelaide Cancer Centre||Recruiting|
|Kurralta Park, South Australia, Australia|
|Contact +61 8 8292 2220|
|Principal Investigator: Anna Mislang, MBBS|
|Clayton, Victoria, Australia|
|Contact: Sophia Frentzas, Dr +61 3 8572 2429 firstname.lastname@example.org|
|Principal Investigator: Sagun Parakh, MBBS|
|Peter MacCallum Cancer Centre||Not yet recruiting|
|Melbourne, Victoria, Australia|
|Contact: Linda Mileshkin, MBBS +61 3 8559 5000|