JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

NCT06892431 | Not Yet Recruiting Phase 2

• 1 other identifier: JMT101-019
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) per RECIST v1.1

  Up to approximately 30 months after the first participant is enrolled

Secondary Outcomes (8)

• Disease control rate (DCR) per RECIST 1.1

  Up to approximately 30 months after the first participant is enrolled

• Duration of response (DoR) per RECIST 1.1

  Up to approximately 30 months after the first participant is enrolled

• Progression free survival (PFS) per RECIST 1.1

  Up to approximately 30 months after the first participant is enrolled

• Overall survival(OS)

  Up to approximately 30 months after the first participant is enrolled

• Frequency and severity of AEs (NCI CTCAE 5.0)

  Up to approximately 30 months after the first participant is enrolled

Study Arms (3)

JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;

EXPERIMENTAL

Treatment Group A: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2, intravenous drip, Q4W.

Drug: Mitoxantrone Hydrochloride Liposome; Drug: JMT101 injection

JMT101 + Mitoxantrone Liposome;

EXPERIMENTAL

Treatment Group B: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2, intravenous drip, Q4W.

Drug: Mitoxantrone Hydrochloride Liposome; Drug: JMT101 injection

Monotherapy chemotherapy regimens selected by the investigator.

ACTIVE COMPARATOR

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

Drug: Capecitabine; Drug: Docetaxel injection; Drug: Gemcitabine hydrochloride for injection

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

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

JMT101 + Mitoxantrone Liposome;; JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;

JMT101 injection DRUG

JMT101 Injection 6 mg/kg, intravenous drip,

Also known as: Recombinant Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Injection

JMT101 + Mitoxantrone Liposome;; JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;

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);

Monotherapy chemotherapy regimens selected by the investigator.

Docetaxel injection DRUG

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

Monotherapy chemotherapy regimens selected by the investigator.

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;

Monotherapy chemotherapy regimens selected by the investigator.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG PS score of 0-1;
• Estimated lifespan of at least 3 months;
• Have adequate organ function, laboratory test meets the following criteria (has not received transfusion or hematopoietic stimulating factor treatment within 14 days):(1)Hematology: a. Absolute neutrophil count ≥1.5×109/L; b. Platelet count ≥100×109/L; c. Hemoglobin ≥90 g/L.(2)Liver function: a. Total bilirubin ≤1.0×ULN; for participants with metastases to liver, total bilirubin ≤1.5×ULN; b. Alanine aminotransferase and aspartate aminotransferase ≤1.5×ULN, for participants with metastases to liver, alanine aminotransferase and aspartate aminotransferase ≤2.5×ULN. (3)Renal function: Creatinine ≤1.5×ULN; or creatinine clearance ≥50 mL/min (calculated according to the Cockcroft-Gault formula).(4)Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
• Women of childbearing potential must use highly effective contraception.

You may not qualify if:

• 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;
• Have received local radiotherapy (including radionuclide therapy such as strontium-89) within 2 weeks prior to the first dose of study drug; have received irradiation of more than 30% of bone marrow or have received wide-field radiotherapy within 4 weeks prior to randomization;
• Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;
• Have undergone major surgery or had severe traumatic injury within 4 weeks prior to the first dose of study drug, or it is expected to undergo major surgery during the study period. Some clinical procedures such as vascular access placement and aspiration biopsy are allowed;
• Currently receiving long-term immunosuppression therapy (e.g., cyclosporine) or have other diseases requiring treatment with systemic corticosteroids (i.e., prednisone over 10 mg/day or other corticosteroids at equivalent physiological doses), excluding those receiving local glucocorticoid therapy via nasal spray, inhalation, or other routes;
• Participants with metastases to meninges or spinal cord compression; participants with symptomatic and/or unstable brain metastasis, unless the participant has completed definitive treatment and has been stable for at least 2 weeks prior to randomization without the need for steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;
• Subjects who have taken strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose of study drug, or who cannot suspend the use of strong CYP3A4 inducers and inhibitors during the study;
• Participants with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or immunodeficiency congenital diseases, or a history of organ transplant;
• Presence of active infection (e.g., the subject is receiving anti-infection therapy), including uncontrolled active hepatitis b, active hepatitis c, active syphilis, active tuberculosis, etc.; Patients with a history of human hepatitis B virus (HBV) infection may be considered for enrollment if they meet all of the following criteria: a. Have no co-infection with hepatitis C virus (HCV) and no history of HCV infection; b. Participants with active HBV infection may also be enrolled if they can receive at least 2 weeks of antiviral therapy before starting study treatment, and after treatment their HBV DNA is less than 100 IU/mL and transaminases are less than 1×ULN.
• Severe or uncontrolled cardiovascular disorder requiring treatment, including but not limited to
• Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally, or previous subtotal small bowel resection, etc., and have conditions that seriously affect gastrointestinal absorption as judged by the investigator.
• Prior to initiating treatment, have not yet adequately recovered (i.e., to ≤ Grade 1, excluding hypodynamia or alopecia) from toxicities and/or complications caused by any interventions;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Neoplasms

Interventions

Capecitabine; Docetaxel; Gemcitabine; Injections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, positive-controlled Phase II

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 24, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share