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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05435742




Registration number
NCT05435742
Ethics application status
Date submitted
14/06/2022
Date registered
28/06/2022

Titles & IDs
Public title
SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Repeated Subcutaneous Administration of SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) After the End of Chemotherapeutic Treatment
Secondary ID [1] 0 0
SB211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced Peripheral Neuropathy (CIPN) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SON-080

Experimental: SON-080 Dose Level 1 - 20 µg SON-080 SC administration TIW

Experimental: SON-080 Dose Level 2 - 60 µg SON-080 SC administration TIW

Placebo comparator: Matching Placebo - Matching placebo 20 µg SON-080 SC administration TIW


Treatment: Other: SON-080
Recombinant human interleukin-6 (rhIL-6)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety of SON-080
Timepoint [1] 0 0
Through study completion, an average of 24 weeks
Secondary outcome [1] 0 0
Evaluate the pharmacokinetics of SON-080
Timepoint [1] 0 0
Through study completion, an average of 24 weeks
Secondary outcome [2] 0 0
Evaluate the immunogenicity of SON-080
Timepoint [2] 0 0
Through study completion, an average of 24 weeks
Secondary outcome [3] 0 0
Evaluate the preliminary efficacy of SON-080
Timepoint [3] 0 0
Weeks 5, 9, and 12 of treatment, as well as 4 and 12 weeks after the end of treatment.

Eligibility
Key inclusion criteria
* Age =18 years, inclusive, at the time of Screening.
* Have persistent CIPN at 3 months or more after chemotherapeutic treatment arrest (QLQ-CIPN20 score of 30 to 100).
* Have a history of cancer that is stable or in remission at the time of study entry.
* Have a history of treatment with a chemotherapeutic agent in the taxane, organoplatin, or vinca alkaloid family.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at Screening.
* Must have adequate organ function, defined as:

* Hematologic function defined as National Cancer Institute (NCI) CTCAE Grade 1 or less for all blood parameters.
* Renal function defined as calculated creatinine clearance or radioisotope glomerular filtration rate >60 mL/min/1.73 m2 or normal serum creatinine with a maximum serum creatinine of 1.7 mg/dL for males and 1.4 mg/dL for females.
* Hepatic Function defined as:
* Alanine aminotransferase (ALT) =3 × the upper limit of normal (ULN) for age.
* Total bilirubin =1.5 × ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).
* Either the patient or the caregiver must be willing and able to administer SC treatment in an at-home setting after training.
* Female patients of childbearing potential who are not currently pregnant or lactating must have a negative serum pregnancy test (beta-human chorionic gonadotropin [ß HCG]) on day 1 and agree to abstinence or use a highly effective method of birth control for 30 days before the study, during the study, and for 30 days after the last dose of study intervention. Females who are not of childbearing potential (have had a tubal ligation, hysterectomy, or bilateral oophorectomy, or are = 1-year postmenopause) or have a partner who has had a vasectomy do not need to use any contraception.
* Nonchildbearing potential is defined as surgically sterile (documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea). If necessary, a follicle-stimulating hormone (FSH) level = 35 IU/L at Screening will be considered confirmatory in the absence of a clear postmenopausal history. If a patient is not sexually active, but becomes active, then she and her male partner must use adequate contraception.
* Male patients and their female partners must agree to use adequate contraception (including a barrier method) during the study and for 30 days after the last dose of SON-080. Contraception guidance is described in the protocol.
* If a patient is not sexually active, but becomes active, then he and his female partner must use adequate contraception. Male patients must refrain from sperm donation for 90 days after the last dose of SON-080.
* Must be willing and able to provide voluntary written informed consent to participate in the study.
* Must be able to communicate well with the Investigator and/or study site personnel and to comply with the requirements of the entire study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of current alcohol or drug dependence.
* Evidence for other cause of chemotherapeutic neuropathy, e.g., use of colchicine, amiodarone, thalidomide, vitamin B12 deficiency, etc.
* Unresolved toxicities from prior anticancer therapy, defined as not having resolved to baseline or to CTCAE Grade 1, except for alopecia, or to the levels dictated in the inclusion/exclusion criteria.
* Active infection with SARS-CoV-2, as determined by local SOPs for testing during Screening.
* History of hepatic disease or active clinically significant liver function test results, defined as chronically abnormal ALT, aspartate aminotransferase (AST), total bilirubin and fractionated bilirubin, and alkaline phosphatase >1.5 × the ULN. Note: Isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%.
* Diagnosis of or positive screening result for hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV)-1 or HIV-2.
* Known allergies to any of the ingredients of the medicinal product or to acetaminophen.
* History of brain metastases.
* Diagnosed with lymphoma, Kaposi's sarcoma, or multiple myeloma.
* Significant unstable vascular disease, as judged by the Investigator.
* Any other investigational drug in the 4 weeks preceding treatment administration. Note: COVID-19 vaccines will be allowed if administered more than 14 days before the first dose administration.
* Clinical history of a thrombosis, deep vein thrombosis, or pulmonary embolus in the past year.
* Other serious concurrent medical condition which, in the opinion of the Investigator, would preclude inclusion in the study.
* History of any active infection within 14 days before the first dose of SON-080, if deemed clinically significant by the Investigator and Sponsor.
* Concurrent conditions that could interfere with safety and/or tolerability measurements.
* Pregnant and/or lactating.
* Unable or unwilling to cooperate with the Investigator for any reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2024
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritis Research - Camberwell
Recruitment postcode(s) [1] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sonnet BioTherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Kenney, MD
Address 0 0
Sonnet BioTherapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05435742