Safety and Efficacy of JMKX000189 for Chemotherapy-Induced Peripheral Neuropathy

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).

Study Overview

• Status: Not yet recruiting
• Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Drug: JMKX000189; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fawei Wu; Phone Number: +86 15720614080; Email: wufawei@jeyoupharma.com

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital Fudan University
    • Contact: Ruofan Huang; Phone Number: (+86)021-52888045; Email: ruofanhuang@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

  1. 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;
  2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: Placebo; Placebo administered orally.
Experimental: JMKX000189 Dose 1	Drug: JMKX000189; JMKX000189 administered orally.
Experimental: JMKX000189 Dose 2	Drug: JMKX000189; JMKX000189 administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).	up to 6 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shanghai Jeyou Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xiaojie Wu, Huashan Hospital; Principal Investigator: Ruofan Huang, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JMKX000189-C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No