A Study of AK119 (Anti-CD73) in Combination With AK104 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: NCT04572152|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumors||Biological: AK119 Biological: AK104||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumors.|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: AK119/ AK104
Subjects will receive AK119 by intravenous administration.
After AK119 IV, on the same day subjects will receive AK104 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 study drug ]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 6 weeks ]DLTs will be assessed during the first 6 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 6 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.
- Maximum observed concentration (Cmax) of AK119 and AK104 [ Time Frame: From first dose of study drug through 30 days after last dose of study drug ]The endpoints for assessment of PK include serum concentrations of AK119 and AK104 at different timepoints after study drug administration.
- Minimum observed concentration (Cmin) of AK119 and AK104 at steady state [ Time Frame: From first dose of study drug through 30 days after last dose of study drug ]The endpoints for assessment of PK include serum concentrations of AK119 and AK104 at different timepoints after study drug administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of study drug through 90 days after last dose of study drug ]The immunogenicity of AK119 and AK104 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): NCT04572152
|Contact: Kon Yew Kwek||+86 (0760) 8987 firstname.lastname@example.org|
|Australia, New South Wales|
|Blacktown Cancer and Haematology Centre (Blacktown Hospital)|
|Blacktown, New South Wales, Australia, 2148|
|Contact: Raymond TANGUNAN email@example.com|
|Contact: Amanda BRYANT firstname.lastname@example.org|
|Principal Investigator: Matteo CARLINO, MBBS PHD|
|ICON Cancer Centre|
|South Brisbane, Queensland, Australia, 4101|
|Contact: Adam STONELEY email@example.com|
|Contact: Jane HOLT firstname.lastname@example.org|
|Principal Investigator: Jim COWARD, MBBS, MRCP (UK), FR|
|Australia, South Australia|
|Ashford Cancer Centre|
|Adelaide, South Australia, Australia, 5037|
|Contact: Sue YEEND email@example.com|
|Contact: Tanya DAYMAN firstname.lastname@example.org|
|Principal Investigator: Amy HSIEH, MBBS FRACP|
|Clayton, Victoria, Australia, 3168|
|Contact: Penny MACQUIRE Penelope.Macquire@monashhealth.org|
|Contact: Kelly HOFFMAN|
|Principal Investigator: Sophia FRENTZAS, MBBS PHD|
|Alfred Health (The Alfred Hospital)|
|Melbourne, Victoria, Australia, 3004|
|Contact: Cheryl-Ann HAWKINS N.Cross@alfred.org.au|
|Principal Investigator: Benjamin MARKMAN, MBBS (HONS) FRACP|