Safety and Efficacy of JMKX000189 for Chemotherapy-Induced Peripheral Neuropathy

NCT07601386 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX000189-C101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

  up to 6 months.

Secondary Outcomes (4)

• The changes in average pain score on brief pain inventory-short form (BPI-SF) from the baseline

  up to 6 months.

• The changes in numbness score on FACT/GOG-Ntx from the baseline

  up to 6 months.

• Area Under the Curve over the Dosing Interval during Steady State (AUC0-tau)

  up to 6 months.

• Maximum Concentration during Steady State (Cmax,ss)

  up to 6 months.

Study Arms (3)

JMKX000189 Dose 1

EXPERIMENTAL

Drug: JMKX000189

JMKX000189 Dose 2

EXPERIMENTAL

Drug: JMKX000189

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

JMKX000189 DRUG

JMKX000189 administered orally.

JMKX000189 Dose 1; JMKX000189 Dose 2

Placebo OTHER

Placebo administered orally.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Jeyou Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, China

Location

Study Officials

• Ruofan Huang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Xiaojie Wu

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fawei Wu

CONTACT

+86 15720614080; wufawei@jeyoupharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 22, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)