Salivary Gland Cancer
Conditions
Interventions
The single-drug ACC group:Intravenous injection of MRG003
The non-ACC single-drug group:Intravenous injection of MRG003
Combined ACC group:Injection of MRG003 + Putilimab
Combined with non-ACC group:Injection of MRG003 + Putilimab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient must meet all of the following inclusion criteria: 1. Voluntarily sign the informed consent form and follow the protocol requirements. 2. The age of the subject on the day of signing the informed consent form is >= 18 years old, and gender is not restricted. 3. The expected survival period is >= 12 weeks. 4. Histopathologically confirmed as unresectable or refractory salivary gland cancer, including major subtypes such as adenoid cystic carcinoma, mucinous epidermoid carcinoma, and adenocarcinoma; and immunohistochemistry confirmed with EGFR expression or positivity. 5. For patients diagnosed with adenoid cystic carcinoma (ACC) or the subtype of acinar cell carcinoma, one of the following conditions must be met: there is evidence of imaging progression within 6 months before enrollment, or there is new or worsening tumor-related symptoms. 6. For non-ACC subtypes, those in the combined treatment cohort must meet either PD-L1 CPS >= 1 or TMB >= 10. 7. The subject is able to provide a tumor primary or metastatic site specimen for pathological testing (wax blocks, wax-embedded sections, or fresh tissue sections are acceptable), using the most recent archived tumor tissue specimen. If no archived tissue specimen is available, a new biopsy must be performed. 8. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), the subject has at least one measurable lesion at baseline (the longest diameter of the lesion on CT scan >= 10 mm, if the lesion is a lymph node, the shortest diameter >= 15 mm; the measurable lesion should not have received radiotherapy, but if it is a measurable lesion within the irradiated field of previous radiotherapy or a lesion after local treatment and confirmed to have progressed, it can also be selected as a target lesion). 9. Physical condition score ECOG 0 or 1 within 7 days before administration. 10. Organ function levels must meet the following requirements: ? Bone marrow: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, hemoglobin >= 90 g/L, and no blood transfusion or biological response modifiers (such as granulocyte and erythropoietin growth factors) treatment within 14 days before the first administration. ? Liver: For patients without liver metastasis, serum total bilirubin (TBIL) = 50 mL/min (according to the Cockcroft and Gault formula). ? Coagulation function: International normalized ratio (INR) <= 1.5 × ULN, and activated partial thromboplastin time (aPTT) <= 1.5 × ULN (allowing for low-dose anticoagulants such as aspirin 100 mg/day). 11. Male subjects with fertility and female subjects of childbearing age who are willing to take effective contraceptive measures from the time of signing the informed consent form until 6 months after the last administration of the investigational drug; female subjects of childbearing age include premenopausal women and those within 2 years after menopause. The blood pregnancy test result within <= 7 days before the first administration of the investigational drug must be negative.
Exclusion criteria
Exclusion criteria: 1.History of other malignancies within the past 5 years, except for cured cervical carcinoma, thyroid carcinoma, or basal cell carcinoma of the skin. 2.Prior treatment with any of the following: Treatment with an MMAE-loaded antibody–drug conjugate (ADC) within 3 months before the first dose. Exposure to any investigational agent in another clinical trial within 28 days before the first dose. Any antineoplastic therapy (including but not limited to chemotherapy, radiotherapy, or targeted therapy) within 28 days before the first dose. Major surgery within 28 days before the first dose without full recovery, or planned major surgery within the first 12 weeks after study drug administration. 3.HER2-positive patients at baseline who have not received prior HER2-targeted therapy. 4.Symptomatic brain or leptomeningeal metastases, or prior treatment for brain metastases within 3 months before the first dose. 5.Clinically significant pleural, peritoneal, or pericardial effusion requiring drainage. 6.Any severe or uncontrolled systemic disease deemed by the investigator to be unsuitable, including poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg), inadequately controlled diabetes mellitus, or signs of active bleeding. 7.Uncontrolled cardiac conditions, including NYHA Class >II heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmias requiring treatment. 8.Evidence of active infection, including: Hepatitis B (HBsAg positive and HBV DNA >=2000 IU/mL, after exclusion of drug-induced or other causes); Hepatitis C (anti-HCV positive and HCV RNA above the lower limit of detection); HIV infection; or any uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infection, unless treated and resolved before study drug administration. 9.History of hypersensitivity to pucotenlimab or any component of MRG003 (histidine, histidine hydrochloride, sucrose, mannitol, polysorbate 80), or Grade =3 hypersensitivity to macromolecular protein preparations or monoclonal antibodies. 10.History of primary immunodeficiency or active autoimmune disease requiring immunosuppressive therapy or systemic corticosteroids (=10 mg/day prednisone or equivalent) within 2 weeks before enrollment. Note: Patients with Type 1 diabetes, stable hypothyroidism on hormone replacement (including autoimmune thyroiditis), psoriasis or vitiligo not requiring systemic therapy are eligible. Topical, inhaled, or short-term (=7 days) corticosteroids for non-autoimmune, infrequent allergic conditions are permitted. 11.History of interstitial pneumonitis, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm. 12.Toxicities from prior antineoplastic therapy have not resolved to =Grade 1 per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation (any grade allowed), or Grade 2 hypothyroidism stable on hormone replacement. 13.Peripheral neuropathy >Grade 1. 14.Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial (e.g., alcohol or drug abuse).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period;Disease control rate;Progression-free survival period;Duration of relief; | — |
Countries
China
Contacts
Public ContactDongmei Ji
Fudan University Shanghai Cancer Center
Outcome results
None listed