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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07601386

Enrollment

Registered

2026-05-22

Start date

2026-05-10

Completion date

2027-06-20

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

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).

Interventions

DRUGJMKX000189

JMKX000189 administered orally.

OTHERPlacebo

Placebo administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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.

Countries

China

Contacts

CONTACTFawei Wu

wufawei@jeyoupharma.com+86 15720614080

PRINCIPAL_INVESTIGATORRuofan Huang

Huashan Hospital

PRINCIPAL_INVESTIGATORXiaojie Wu