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SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SON-080
Sponsored by
Sonnet BioTherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/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.

Sites / Locations

  • Emeritis ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SON-080 Dose Level 1

SON-080 Dose Level 2

Matching Placebo

Arm Description

20 µg SON-080 SC administration TIW

60 µg SON-080 SC administration TIW

Matching placebo 20 µg SON-080 SC administration TIW

Outcomes

Primary Outcome Measures

Evaluate the safety of SON-080
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 Outcome Measures

Evaluate the pharmacokinetics of SON-080
Single- and multiple-dose PK parameters of SON-080
Evaluate the immunogenicity of SON-080
Anti-SON-080 antibody determination
Evaluate the preliminary efficacy of SON-080
Change from baseline in Quality-of-Life Questionnaire-CIPN 20-item scale

Full Information

First Posted
June 14, 2022
Last Updated
February 23, 2023
Sponsor
Sonnet BioTherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05435742
Brief Title
SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonnet BioTherapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy (CIPN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SON-080 Dose Level 1
Arm Type
Experimental
Arm Description
20 µg SON-080 SC administration TIW
Arm Title
SON-080 Dose Level 2
Arm Type
Experimental
Arm Description
60 µg SON-080 SC administration TIW
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo 20 µg SON-080 SC administration TIW
Intervention Type
Biological
Intervention Name(s)
SON-080
Intervention Description
Recombinant human interleukin-6 (rhIL-6)
Primary Outcome Measure Information:
Title
Evaluate the safety of SON-080
Description
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.
Time Frame
Through study completion, an average of 24 weeks
Secondary Outcome Measure Information:
Title
Evaluate the pharmacokinetics of SON-080
Description
Single- and multiple-dose PK parameters of SON-080
Time Frame
Through study completion, an average of 24 weeks
Title
Evaluate the immunogenicity of SON-080
Description
Anti-SON-080 antibody determination
Time Frame
Through study completion, an average of 24 weeks
Title
Evaluate the preliminary efficacy of SON-080
Description
Change from baseline in Quality-of-Life Questionnaire-CIPN 20-item scale
Time Frame
Weeks 5, 9, and 12 of treatment, as well as 4 and 12 weeks after the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel DaFonseca
Phone
1-609-451-3912
Email
clinical@sonnetbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kenney, MD
Organizational Affiliation
Sonnet BioTherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Emeritis Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
King Cheung, MD
Phone
61 3 9509 6166
Email
info@emeritusresearch.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)

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