Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 1NCT06860789
AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Phase 1 study testing AK135 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Akeso at 2 sites in China.
Trial summary
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with malignant tumor Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- AK135
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically documented malignant tumor.
- Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.
- Diagnosed with Chemotherapy-Induced Peripheral Neuropathy (CIPN) by an oncologist or neurologist, with at least grade 2 NCI Common Terminology Criteria for Adverse Events.
- Must have pain and/or numbness due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms.
- Adequate organ function.
Who cannot join
- Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK135.
- Concurrent and/or scheduled to start any anti-tumor treatment that may cause Chemotherapy-Induced Peripheral Neuropathy (CIPN) within 3 months after the first dose of AK135.
- Concurrent and/or scheduled to start any anti-tumor treatment that may cause hand-foot skin reaction within 3 months after the first dose of AK135.
- Presence with other illnesses may result in peripheral neuropathy including, autoimmune diseases, diabetes and metabolic syndrome, peripheral vascular disease, infections, nerve injury or compression, vitamin deficiencies, and so on.
- Skin lesions may affect the assessment of peripheral neuropathy.
- Unresolved toxicities from prior anti-cancer therapy within 2 weeks before the first dose of AK135, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or levels specified in the inclusion/exclusion criteria, except for alopecia, and neuropathy.
- Known allergy or reaction to any component of the AK135 formulation. History of severe hypersensitivity reactions to other mAbs.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Sun Yat-sen Memorial Hospital
Guangzhou
YAO, HERUI
Shanghai GoBroad Cancer Hospital
Shanghai
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK135 for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients With Malignant Tumors
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with malignant tumor
- Being tested
- AK135
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK135Drug
IV infusion, specified dose with specified treatment frequency
| Study group | Role | What they receive |
|---|---|---|
| AK135 | Experimental | Each subject will receive a single dose of AK135 every 2-week cycle (Q2W) or every 1-week cycle (QW) or every 3-week cycle (Q3W). Receives: Drug: AK135 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of participants with adverse events
Measured: From time ICF is signed until 90 days after last dose of AK135
DLT
Measured: During the first treatment cycle of AK135 （14 days）
Secondary outcomes (7)
EORTC-QLQ-CIPN20
Patient-assessed European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
Measured: through study completion, an average of 12 weeks
BPI-SF
Patient-assessed Brief Pain Inventory-Short Form
Measured: through study completion, an average of 12 weeks
CTCAE-Neuropathy
Physician-assessed Common Terminology Criteria for Adverse Events-Neurotoxicity
Measured: through study completion, an average of 12 weeks
Cmax of AK135
Measured: through study completion, an average of 12 weeks
AUC
Measured: through study completion, an average of 12 weeks
t1/2
Measured: through study completion, an average of 12 weeks
ADAs
Number of subjects who develop detectable anti-drug antibodies
Measured: From first dose of study drug through 30 days after last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start28 Feb 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860789
- Sponsor's protocol ID
- AK135-101
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK135 for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT06860789
- Acronym / sponsor ID
- AK135-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2025 (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.
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with malignant tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK135 | Experimental | Drug: AK135Each subject will receive a single dose of AK135 every 2-week cycle (Q2W) or every 1-week cycle (QW) or every 3-week cycle (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written and signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically documented malignant tumor.
- Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.
Key exclusion criteria (7 listed)
- Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK135.
- Concurrent and/or scheduled to start any anti-tumor treatment that may cause Chemotherapy-Induced Peripheral Neuropathy (CIPN) within 3 months after the first dose of AK135.
- Concurrent and/or scheduled to start any anti-tumor treatment that may cause hand-foot skin reaction within 3 months after the first dose of AK135.
- Presence with other illnesses may result in peripheral neuropathy including, autoimmune diseases, diabetes and metabolic syndrome, peripheral vascular disease, infections, nerve injury or compression, vitamin deficiencies, and so on.
- Skin lesions may affect the assessment of peripheral neuropathy.
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 |
|---|---|---|
| AK135IV infusion, specified dose with specified treatment frequency | Drug | AK135 |
Primary outcome
Adverse events
Time frame: From time ICF is signed until 90 days after last dose of AK135
Incidence and severity of participants with adverse events
DLT
Time frame: During the first treatment cycle of AK135 （14 days）
7 secondary outcomes
EORTC-QLQ-CIPN20
Time frame: through study completion, an average of 12 weeks
BPI-SF
Time frame: through study completion, an average of 12 weeks
CTCAE-Neuropathy
Time frame: through study completion, an average of 12 weeks
Cmax of AK135
Time frame: through study completion, an average of 12 weeks
AUC
Time frame: through study completion, an average of 12 weeks
t1/2
Time frame: through study completion, an average of 12 weeks
ADAs
Time frame: From first dose of study drug through 30 days after last dose of study drug.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK135 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Akeso at 2 sites in China.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xufang Yu (+86(0760)8987399, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From time ICF is signed until 90 days after last dose of AK135). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.