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 : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Malignant||Drug: AK112||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Estimated Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
AK112 IV every 2 weeks (q2w)
AK112 is a PD1/VEGF bispecific antibody.
- Number 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 ]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.
- 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 for ≥8 weeks) 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 [ 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) 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.
- Minimum observed concentration (Cmin) of AK112 at steady state [ 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: Xiaoping Jin, PhD||+86 (0760) 8987 email@example.com|
|Australia, New South Wales|
|Scientia Clinical Research Ltd||Not yet recruiting|
|Randwick, New South Wales, Australia, 2031|
|Contact +61 2 9382 5811|
|Principal Investigator: Charlotte Lemech, MBBS|
|ICON Cancer Foundation||Not yet recruiting|
|South Brisbane, Queensland, Australia, 4101|
|Contact +61 3737 4500|
|Principal Investigator: Jermain Coward, MBBS|
|Australia, South Australia|
|Adelaide Cancer Centre||Not yet recruiting|
|Kurralta Park, South Australia, Australia, 5037|
|Contact +61 8 8292 2220|
|Principal Investigator: Dusan Kotasek, MBBS|
|Monash Health||Not yet recruiting|
|Clayton, Victoria, Australia, 3168|
|Contact +61 3 8572 2429|
|Principal Investigator: Ben Markman, MBBS|