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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03529526
Registration number
NCT03529526
Ethics application status
Date submitted
8/05/2018
Date registered
18/05/2018
Titles & IDs
Public title
Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors
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Scientific title
An Open-Label, Multi-center, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of KN046 in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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KN046-AUS-001
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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 Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - KN046
Experimental: KN046 -
Treatment: Drugs: KN046
The modified phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of KN046: 0.3 mg/kg,1 mg/kg,3 mg/kg,5 mg/kg,10 mg/kg.
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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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Number of participants with dose limiting toxicity (DLT)
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Assessment method [1]
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An DLT is defined as a =Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare causing local pain at sites of known or suspected tumor, localized rash, or a transient =Grade 3 infusion reaction) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
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Timepoint [1]
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During the first cycle (4 weeks) of treatment.
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Secondary outcome [1]
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Number of participants with 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 KN046 and/or pharmaceutical product(s) temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [1]
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From the time of informed consent signed through 90 days after the last dose of KN046,up to 2 years.
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Secondary outcome [2]
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Objective response rate (ORR)
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Assessment method [2]
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The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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Timepoint [2]
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From first dose of KN046 through 90 days after last dose of KN046, up to 2 years.
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Secondary outcome [3]
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Duration of response (DoR)
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Assessment method [3]
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Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
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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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Progression-free survival (PFS)
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Assessment method [4]
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Progression-free survival is defined as the time from the start of treatment with KN046 until the first documentation of disease progression or death due to any cause, whichever occurs first.
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Timepoint [4]
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From first dose of KN046 through 90 days after last dose of KN046, up to 2 years.
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Secondary outcome [5]
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Clinical benefit rate (CBR)
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Assessment method [5]
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Clinical benefit rate is defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD) to KN046 intervention.
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Timepoint [5]
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From first dose of KN046 through 90 days after last dose of KN046, up to 2 years.
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Secondary outcome [6]
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Area under the curve (AUC) of KN046
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Assessment method [6]
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The endpoints for assessment of PK of KN046 include serum concentrations of KN046 at different timepoints after KN046 administration.
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Timepoint [6]
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From first dose of KN046 through 90 days after last dose of KN046, up to 9 months.
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Secondary outcome [7]
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Maximum observed concentration (Cmax) of KN046
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Assessment method [7]
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The endpoints for assessment of PK of KN046 include serum concentrations of KN046 at different timepoints after KN046 administration.
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Timepoint [7]
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From first dose of KN046 through 90 days after last dose of KN046, up to 9 months.
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Secondary outcome [8]
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Minimum observed plasma concentration (Ctrough) of KN046 at steady state
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Assessment method [8]
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The endpoints for assessment of PK of KN046 include serum concentrations of KN046 at different timepoints after KN046 administration.
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Timepoint [8]
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From first dose of KN046 through 90 days after last dose of KN046, up to 9 months.
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Secondary outcome [9]
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
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Assessment method [9]
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The immunogenicity of KN046 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
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Timepoint [9]
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Assessed before KN046 infusion in Cycle 1, 2, 3, 4, 5, 6 and at the mandatory Safety Follow-up Visit, maxium up to 2 years.
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Secondary outcome [10]
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Number of subjects who develop detectable neutralizing ADA (NADA)
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Assessment method [10]
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The neutralizing ADA will be assessed by summarizing the number of subjects who develop detectable neutralizing ADA .
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Timepoint [10]
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Assessed before KN046 infusion in Cycle 1, 2, 3, 4, 5, 6 and at the mandatory Safety Follow-up Visit, maxium up to 2 years.
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Eligibility
Key inclusion criteria
1. The subject must sign the informed consent form prior to the conduct of any study related procedures that are required during the screening period and are not considered part of standard of care.
2. Subjects must have histologic or cytologic confirmed Advanced solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Adequate organ function within 3 weeks prior to initial treatment.
5. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.
6. Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
7. Female patients must have a negative serum or urine pregnancy test
8. Female patients must not be breastfeeding.
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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. Subjects with brain metastases or leptomeningeal are excluded.
2. Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-interventional study.
3. Any kind of immunotherapy within 6 weeks of the first dose of study treatment.
4. Prior systemic cytotoxic chemotherapy, other anticancer drugs or growth factor within 28 days of the first dose of study treatment, or any investigational agents within 5 half-lives of the product.
5. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the 1st dose of study treatment, or have an anticipated need for major surgery during the study.
6. Palliative radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the 1st dose of study treatment.
7. Prior treatment or with sequential monotherapy with anti-CTLA-4 and anti-PD-1/PD-L agents.
8. Patients who have received monotherapy with PD-L1 / PD-1, CTLA4 or other antibodies and had intolerable toxicity or required steroids to manage toxicity.
9. History of autoimmune or inflammatory disorders.
10. A current or prior use of immunosuppressive medication within 14 days of the 1st dose of study treatment.
11. Suspected latent tuberculosis infection, confirmed by Mantoux test and a chest x-ray.
12. Any unresolved toxicity NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
13. Any factors that increase the risk of QT (ECG interval measured from the onset of the QRS complex to the end of the T wave) interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age) or mean QTc>470 msec.
14. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus 1/2 antibody (HIV 1/2 Ab).
15. History of severe allergic reactions to any unknown allergens or to parenteral administered recombinant protein product.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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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
Other
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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
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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
21/05/2018
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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
30/03/2020
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Actual
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Sample size
Target
21
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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ICON Cancer Care - Southport
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Recruitment postcode(s) [1]
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4125 - Southport
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alphamab (Australia) Co Pty Ltd.
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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
This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) or a biological effective dose (BED), to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN046 as a single agent in adult participants with advanced solid tumors
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Trial website
https://clinicaltrials.gov/study/NCT03529526
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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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Address
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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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Jermaine Coward, A/Prof
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Address
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Country
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Phone
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+61-07-3737-4500
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03529526