Chemotherapy-induced Peripheral Neuropathy (CIPN)
Conditions
Brief summary
The study will be conducted in adult patients with Chemotherapy-induced Peripheral Neuropathy (CIPN) that has been persistent for at least 3 months following completion of chemotherapy. A total of 60 patients will be enrolled in equal numbers of a placebo group and two different SON-080 dose groups. Treatment period will be 12 weeks long and patients will be followed-up for an additional 12 weeks.
Interventions
BIOLOGICALSON-080
Recombinant human interleukin-6 (rhIL-6)
Sponsors
Sonnet BioTherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \[β HCG\]) 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.
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety of SON-080 | Through study completion, an average of 24 weeks | Frequency and severity of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and deaths, by treatment. Note that progression of, or death from, the underlying tumor will not be considered an SAE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacokinetics of SON-080 | Through study completion, an average of 24 weeks | Single- and multiple-dose PK parameters of SON-080 |
| Evaluate the immunogenicity of SON-080 | Through study completion, an average of 24 weeks | Anti-SON-080 antibody determination |
| Evaluate the preliminary efficacy of SON-080 | Weeks 5, 9, and 12 of treatment, as well as 4 and 12 weeks after the end of treatment. | Change from baseline in Quality-of-Life Questionnaire-CIPN 20-item scale |
Countries
Australia
Outcome results
None listed