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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
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
Secondary ID [1] 0 0
AK114-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Malignancy 0 0
Metastasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK114

Experimental: Intervention/treatment - Experimental


Treatment: Drugs: AK114
AK114 administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
From the time of informed consent signed through to 90 days after last dose of study drug
Primary outcome [2] 0 0
Number of participants with a Dose Limiting Toxicity (DLTs)
Timepoint [2] 0 0
Within the first 28 days after receiving the first dose of study drug
Secondary outcome [1] 0 0
Serum pharmacokinetics (PK)
Timepoint [1] 0 0
From first dose of treatment through to 90 days after end of treatment
Secondary outcome [2] 0 0
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Timepoint [2] 0 0
From first dose of study drgu through to 90 days after end of treatment
Secondary outcome [3] 0 0
Objective response rate (ORR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Disease control rate (DCR)
Timepoint [4] 0 0
Up to 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment postcode(s) [1] 0 0
- Kurralta Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Akeso
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics,
and preliminary antitumor activity of AK114.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05200273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex HL Wong, MMedSc
Address 0 0
Akeso
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alex HL Wong, MMedSc
Address 0 0
Country 0 0
Phone 0 0
+86(0760)89873999
Fax 0 0
Email 0 0
global.trials@akesobio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05200273