Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 1/2NCT05435742
SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)
A Phase 1/2 study testing SON-080 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Sonnet BioTherapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- SON-080
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Oct 2022to 17 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- SON-080
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SON-080Biological
Recombinant human interleukin-6 (rhIL-6)
| Study group | Role | What they receive |
|---|---|---|
| SON-080 Dose Level 1 | Experimental | 20 µg SON-080 SC administration TIW Receives: Biological: SON-080 |
| SON-080 Dose Level 2 | Experimental | 60 µg SON-080 SC administration TIW Receives: Biological: SON-080 |
| Matching Placebo | Placebo comparator | Matching placebo 20 µg SON-080 SC administration TIW Receives: Biological: SON-080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (3)
Evaluate the pharmacokinetics of SON-080
Single- and multiple-dose PK parameters of SON-080
Measured: Through study completion, an average of 24 weeks
Evaluate the immunogenicity of SON-080
Anti-SON-080 antibody determination
Measured: Through study completion, an average of 24 weeks
Evaluate the preliminary efficacy of SON-080
Change from baseline in Quality-of-Life Questionnaire-CIPN 20-item scale
Measured: Weeks 5, 9, and 12 of treatment, as well as 4 and 12 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start27 Oct 2022
- Primary completion17 Mar 2024
- Study completion17 Mar 2024
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonnet BioTherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kenney, MD, Study director, Sonnet BioTherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435742
- Sponsor's protocol ID
- SB211
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Baat A, Trinh B, Ellingsgaard H, Donath MY. Physiological role of cytokines in the regulation of mammalian metabolism. Trends Immunol. 2023 Aug;44(8):613-627. doi: 10.1016/j.it.2023.06.002. Epub 2023 Jul 7.
PubMed 37423882
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05435742
- Acronym / sponsor ID
- SB211
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sonnet BioTherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 17 Mar 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SON-080 Dose Level 1 | Experimental | Biological: SON-08020 µg SON-080 SC administration TIW |
| SON-080 Dose Level 2 | Experimental | Biological: SON-08060 µg SON-080 SC administration TIW |
| Matching Placebo | Placebo comparator | Biological: SON-080Matching placebo 20 µg SON-080 SC administration TIW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (17 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SON-080Recombinant human interleukin-6 (rhIL-6) | Biological | Matching Placebo, SON-080 Dose Level 1, SON-080 Dose Level 2 |
Primary outcome
Evaluate the safety of SON-080
Time frame: 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.
3 secondary outcomes
Evaluate the pharmacokinetics of SON-080
Time frame: Through study completion, an average of 24 weeks
Evaluate the immunogenicity of SON-080
Time frame: Through study completion, an average of 24 weeks
Evaluate the preliminary efficacy of SON-080
Time frame: Weeks 5, 9, and 12 of treatment, as well as 4 and 12 weeks after the end of treatment.
Results and safety
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 37423882de Baat A, Trinh B, Ellingsgaard H, Donath MY. Physiological role of cytokines in the regulation of mammalian metabolism. Trends Immunol. 2023 Aug;44(8):613-627. doi: 10.1016/j.it.2023.06.002. Epub 2023 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Kenney, MD study director
Sonnet BioTherapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SON-080 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Sonnet BioTherapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of SON-080 (time frame: Through study completion, an average of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.