JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai JMT-Bio Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and voluntarily sign the written ICF;

Aged 18-75 years old (inclusive), male or female;

Patients with nasopharyngeal cancer who have experienced treatment failure after prior PD-(L)-1 inhibitor therapy and at least second-line chemotherapy (including at least one line containing platinum);

According to RECIST v1.1, there is at least one measurable lesion, and the lesion has not previously undergone radiotherapy or has shown definite progression after radiotherapy;

Disqualifiers

Previously received EGFR monoclonal antibody therapy for recurrent/metastatic nasopharyngeal cancer;

Have previously received treatment with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin exceeds 350 mg/m2 (Equivalent dose calculation for anthracyclines: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg idarubicin = 0.45 mg mitoxantrone);

History of drug allergy to the active or inactive excipients of any study drug, or to drugs with similar chemical structure or class as these two drugs;

Have received anti-tumor treatments within 2 weeks prior to the first dose of study drug, including hormone therapy, biological therapy, immunization therapy, local perfusion of anti-tumor drugs, or traditional Chinese medicines and/or Chinese patent drugs indicated for the treatment of nasopharyngeal cancer;

Trial design

Design model

Parallel

Treatments tested in this trial

Mitoxantrone Hydrochloride Liposome
Drug
Mitoxantrone Hydrochloride Liposome Injection 20mg/m2, or 16mg/m2, intravenous drip, Q4W.
JMT101 injection
Drug
JMT101 Injection 6 mg/kg, intravenous drip,
Capecitabine
Drug
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);
Docetaxel injection
Drug
The dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W.
Gemcitabine hydrochloride for injection
Drug
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;

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;Experimental treatment 2 interventions

Group B: JMT101 + Mitoxantrone Liposome;Experimental treatment 2 interventions

Group C: Monotherapy chemotherapy regimens selected by the investigator.Active comparator 3 interventions