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JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

NCT06892431 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-25

No results posted yet for this study

Summary

This study is a randomized, open-label, multicenter Phase II clinical study, with the objective to assess the efficacy and safety of JMT101 Injection combined with Mitoxantrone Hydrochloride Liposome Injection in patients with recurrent/metastatic nasopharyngeal cancer who have failed at least two prior lines of treatment.

Conditions

  • Recurrent or Metastatic Nasopharyngeal Cancer
  • Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome

Mitoxantrone Hydrochloride Liposome Injection 20mg/m2, or 16mg/m2, intravenous drip, Q4W.

DRUG

JMT101 injection

JMT101 Injection 6 mg/kg, intravenous drip,

DRUG

Capecitabine

The dosage of capecitabine is 1000 mg/m2, taken orally twice daily, administered on D1-14 (Days 1-14) of each cycle, with every 3 weeks as one cycle (Q3W);

DRUG

Docetaxel injection

The dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W.

DRUG

Gemcitabine hydrochloride for injection

The dosage of gemcitabine is 1000 mg/m2, administered via intravenous drip on D1 and D8 (Day 1 and Day 8) of each cycle, Q3W;

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-12-31
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892431 on ClinicalTrials.gov