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).

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.