CIPN - Chemotherapy-Induced Peripheral NeuropathyPhase 1NCT07601386
Safety and Efficacy of JMKX000189 for Chemotherapy-Induced Peripheral Neuropathy
A Phase 1 study testing JMKX000189 in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- JMKX000189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 20 Jun 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
- Aged 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed malignant solid tumors.
- Investigator-confirmed diagnosis of CIPN accompanied with chemotherapy.
- Adequate organ function.
Who cannot join
- Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).
- Toxicities from prior anti-tumor therapy (excluding CIPN) > CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).
- Participants with any of the following cardiovascular diseases or medical history:
- Ischemic heart disease or myocardial infarction, unstable angina, coronary artery spasm, congestive heart failure (NYHA Class III-IV), cardiac arrest, stroke, or transient ischemic attack within 6 months;
- Other clinically significant cardiac disorders per investigator's judgment.
- Presence of active systemic infections.
Show all 10Show fewer
- History of or active primary/secondary immunodeficiency.
- Participation in an interventional clinical trial within 1 month prior to screening.
- Hypersensitivity to any component of the study drug (and its excipients).
- Any condition deemed by the investigator to pose excessive risk, confound results, or interfere with compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital Fudan University
Shanghai
Ruofan Huang, (+86)021-52888045, ruofanhuang@fudan.edu.cn
About this study
Official title: A Phase Ib Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of JMKX000189 Tablets in Patients With Chemotherapy-Induced Peripheral Neuropathy
This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).
- Being tested
- JMKX000189, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000189Drug
JMKX000189 administered orally.
PlaceboOther
Placebo administered orally.
| Study group | Role | What they receive |
|---|---|---|
| JMKX000189 Dose 1 | Experimental | Not described Receives: Drug: JMKX000189 |
| JMKX000189 Dose 2 | Experimental | Not described Receives: Drug: JMKX000189 |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: up to 6 months.
Secondary outcomes (4)
The changes in average pain score on brief pain inventory-short form (BPI-SF) from the baseline
Measured: up to 6 months.
The changes in numbness score on FACT/GOG-Ntx from the baseline
Measured: up to 6 months.
Area Under the Curve over the Dosing Interval during Steady State (AUC0-tau)
Measured: up to 6 months.
Maximum Concentration during Steady State (Cmax,ss)
Measured: up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start10 May 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruofan Huang, Principal investigator, Huashan HospitalXiaojie Wu, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601386
- Sponsor's protocol ID
- JMKX000189-C101
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of JMKX000189 Tablets in Patients With Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07601386
- Acronym / sponsor ID
- JMKX000189-C101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 22 May 2026 (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.
This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMKX000189 Dose 1 | Experimental | Drug: JMKX000189 |
| JMKX000189 Dose 2 | Experimental | Drug: JMKX000189 |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed malignant solid tumors.
- Investigator-confirmed diagnosis of CIPN accompanied with chemotherapy.
Key exclusion criteria (10 listed)
- Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).
- Toxicities from prior anti-tumor therapy (excluding CIPN) > CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).
- Participants with any of the following cardiovascular diseases or medical history:
- Presence of active systemic infections.
- History of or active primary/secondary immunodeficiency.
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 |
|---|---|---|
| JMKX000189JMKX000189 administered orally. | Drug | JMKX000189 Dose 1, JMKX000189 Dose 2 |
| PlaceboPlacebo administered orally. | Other | placebo |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: up to 6 months.
4 secondary outcomes
The changes in average pain score on brief pain inventory-short form (BPI-SF) from the baseline
Time frame: up to 6 months.
The changes in numbness score on FACT/GOG-Ntx from the baseline
Time frame: up to 6 months.
Area Under the Curve over the Dosing Interval during Steady State (AUC0-tau)
Time frame: up to 6 months.
Maximum Concentration during Steady State (Cmax,ss)
Time frame: up to 6 months.
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 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for CIPN - Chemotherapy-Induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
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.
Ruofan Huang principal investigator
Huashan Hospital
Xiaojie Wu principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX000189 in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site 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 6 inclusion and 10 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 22 May 2026. 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 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. 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 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 Fawei Wu (+86 15720614080, wufawei@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). (time frame: up to 6 months.). 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 22 May 2026.