NCT06892431

JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

A Phase II Clinical Study of JMT101 Injection Combined With Mitoxantrone Liposome Injection in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Cancer Who Have Failed At Least Two Prior Lines of Treatment

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be screened within 28 days prior to treatment, and those who meet the inclusion criteria and do not meet any of the exclusion criteria will be enrolled in this study. Enrolled participants will be randomly assigned in a 1:1:1 ratio to the following treatment groups, with each group planned to include 30-50 participants: Mitoxantrone hydrochloride liposome will be administered for up to 6-8 cycles. After 6 cycles of administration, the investigator will decide whether to continue administration up to 8 cycles based on the patient's benefit-risk situation. JMT101 and the investigator-selected single-agent chemotherapy regimen will continue to be administered until progressive disease (PD) as assessed by the investigator according to RECIST v1.1 criteria, intolerable toxicity, withdrawal of informed consent by the subject, initiation of new anti-tumor treatment, loss to follow-up, death, or the end of the study, whichever occurs first.

Conditions

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

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-31
• Completion: 2027-04-30
• First posted: 2025-03-24
• Last updated: 2025-03-25