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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05200273
Registration number
NCT05200273
Ethics application status
Date submitted
7/01/2022
Date registered
20/01/2022
Date last updated
20/01/2022
Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114
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Scientific title
A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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AK114-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors
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Malignancy
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Metastasis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AK114
Experimental: Intervention/treatment - Experimental
Treatment: Drugs: AK114
AK114 administered by subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of adverse events (AEs)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study drug, whether or not considered related to the study drug.
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Timepoint [1]
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From the time of informed consent signed through to 90 days after last dose of study drug
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Primary outcome [2]
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Number of participants with a Dose Limiting Toxicity (DLTs)
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Assessment method [2]
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DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
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Timepoint [2]
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Within the first 28 days after receiving the first dose of study drug
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Secondary outcome [1]
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Serum pharmacokinetics (PK)
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Assessment method [1]
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Serum concentrations of study drug in individual subjects at different time points after study drug administration
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Timepoint [1]
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From first dose of treatment through to 90 days after end of treatment
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Secondary outcome [2]
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
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Assessment method [2]
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The immunogenicity of study drug will be assessed by summarizing the number of subjects who develop detectable ADAs.
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Timepoint [2]
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From first dose of study drgu through to 90 days after end of treatment
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Secondary outcome [3]
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Objective response rate (ORR)
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Assessment method [3]
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The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Disease control rate (DCR)
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Assessment method [4]
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DCR is defined as the number (%) of subjects with best of response of confirmed CR or PR, or stable disease (SD) according to RECIST v1.1.
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Timepoint [4]
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Up to 2 years
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Eligibility
Key inclusion criteria
1. Written and signed informed consent
2. Age = 18
3. Subjects must have histologically or cytologically confirmed advanced or metastatic
solid tumor
4. Subject must have at least one measurable lesion according to RECIST v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status score = 1
6. At the time of Day 1 of the study, subjects with central nervous system (CNS)
metastases must have been treated
7. Available archived tumor tissue sample (block or a minimum of 10 unstained slides of
formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
8. Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment),
where clinically appropriate
9. Adequate organ function
10. Use acceptable method of contraception from screening, and must agree to continue for
120 days after the final dose of investigational product
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of severe hypersensitivity reactions to other monoclonal antibodies
2. History or concurrent gastrointestinal perforation, surgery and wound healing
complications, hemorrhage events
3. Patients with clinically significant cardiovascular disease
4. Subjects with a condition requiring systemic treatment with either corticosteroids (>
10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of investigational product administration
5. Active or prior documented autoimmune disease within the past 2 years
6. History of primary immunodeficiency
7. History of organ transplant or hematopoietic stem cell that requires use of
immunosuppressive medications
8. Known allergy or reaction to any component of the investigational product formulation.
9. History of interstitial lung disease or noninfectious pneumonitis except for those
induced by radiation therapies.
10. Prior treatment with canakinumab.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/03/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2023
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Ashford Cancer Centre - Kurralta Park
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Recruitment postcode(s) [1]
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- Kurralta Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Akeso
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics,
and preliminary antitumor activity of AK114.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05200273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alex HL Wong, MMedSc
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Address
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Akeso
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alex HL Wong, MMedSc
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Address
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Country
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Phone
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+86(0760)89873999
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05200273
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