JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer (NCT06892431) | Clinical Trial Compass
Not Yet RecruitingPhase 2
JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer
150 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Previously received EGFR monoclonal antibody therapy for recurrent/metastatic nasopharyngeal cancer;
What they're measuring
1
Objective response rate (ORR) per RECIST v1.1
Timeframe: Up to approximately 30 months after the first participant is enrolled
✕. 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;