Phase 1, Dose Escalation and Dose Expansion Study of AK117, a CD47-targeting Antibody
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|ClinicalTrials.gov Identifier: NCT04349969|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Malignant||Drug: AK117||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||159 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Relapsed/Refractory Advanced or Metastatic Solid Tumors or Lymphomas|
|Estimated Study Start Date :||April 25, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||September 2023|
An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal
- Number of participants with adverse events (AEs) [ Time Frame: From the time of informed consent signed through 30 days after the last dose of AK117 ]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 ]ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per RECIST Version 1.1 for solid tumor or the Lugano 2014 Classification for lymphoma
- 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).
- Maximum observed concentration (Cmax) of AK117 [ Time Frame: From first dose of AK117 through to 30 days after last dose of AK117 ]The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.
- Minimum observed concentration (Cmin) of AK117 at steady state [ Time Frame: From first dose of AK117 through to 30 days after last dose of AK117 ]The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of AK117 through to 30 days after last dose of AK117 ]The immunogenicity of AK117 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): NCT04349969
|Contact: Kon Yew Kwek, MD||+86 (0760) 8987 firstname.lastname@example.org|
|Australia, New South Wales|
|Sydney, New South Wales, Australia|
|Contact: Adnan Nagrial|
|Principal Investigator: Adnan Nagrial, MBBS|
|ICON Cancer Foundation|
|South Brisbane, Queensland, Australia, 4101|
|Contact +61 3737 4500|
|Principal Investigator: Jermain Coward, MBBS|
|Australia, South Australia|
|Adelaide Cancer Centre|
|Kurralta Park, South Australia, Australia, 5037|
|Contact +61 8 8292 2220|
|Principal Investigator: Anna Mislang, MBBS|
|Heidelberg, Victoria, Australia, 3084|
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|Australia, Western Australia|
|Linear Clinical Research/Sir Charles Gairdner Hospital|
|Nedlands, Western Australia, Australia, 6009|
|Contact +61 (0) 8 6382 5100|
|Principal Investigator: Michael Millward, MBBS|