Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With 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: NCT03352531|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Biological: AK-105||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 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 AK105 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||December 22, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Anti-PD-1 monoclonal antibody; Subjects will receive AK105 by intravenous administration.
- Number of participants with adverse events (AEs) [ Time Frame: From the time of informed consent signed through 90 days after the last dose of AK105 ]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 a Dose Limiting Toxicity (DLT) [ 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.
- 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 AK105 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 AK105 until death due to any cause.
- Area under the curve (AUC) of AK105 [ Time Frame: From first dose of AK105 through 30 days after last dose of AK105 ]The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
- Maximum observed concentration (Cmax) of AK105 [ Time Frame: From first dose of AK105 through 30 days after last dose of AK105 ]The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
- Minimum observed concentration (Cmin) of AK105 at steady state [ Time Frame: From first dose of AK105 through 30 days after last dose of AK105 ]The endpoints for assessment of PK of AK105 include serum concentrations of
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of AK105 through to 90 days after last dose of AK105 ]The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable antidrug 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): NCT03352531
|Contact: Xiaoping Jin, PhD||+86 (0760) 8987 firstname.lastname@example.org|
|Australia, New South Wales|
|St Vincent's Hospital, Sydney (The Kinghorn Cancer Centre)||Not yet recruiting|
|Darlinghurst, New South Wales, Australia, 2010|
|Contact +61 2 9355 5600|
|Principal Investigator: Amy Prawira, MBBS|
|Liverpool Hospital||Not yet recruiting|
|Liverpool, New South Wales, Australia, 2170|
|Contact +61 2 8738 3000|
|Principal Investigator: Paul de Souza, MBBS|
|ICON Cancer Foundation||Recruiting|
|South Brisbane, Queensland, Australia, 4101|
|Contact +61 3737 4500|
|Principal Investigator: Jermain Coward, MBBS|
|Australia, South Australia|
|Adelaide Cancer Centre||Recruiting|
|Kurralta Park, South Australia, Australia, 5037|
|Contact +61 8 8292 2220|
|Principal Investigator: Dusan Kotasek, MBBS|