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: NCT04597541|
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: AK112||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||264 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of AK112 in Advanced Solid Tumor|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2023|
AK112 is a PD1/VEGF bispecific antibody;AK112 is given by intravenous infusion.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597541
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ruihua Xu, MD 86-020-87343135 firstname.lastname@example.org|