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Tests treatment safety and results for Salivary Gland Carcinomas
Official title The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study
ClinicalTrials.gov ID: NCT07464366
What this study is testing
What is MRG 003?
MRG 003 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for salivary gland carcinomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a four-cohort, open-label, single-center Phase II clinical trial aimed at evaluating the efficacy and safety of MRG003 alone or in combination with pertuzumab in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) and other salivary gland cancers (non- ACC SGCs). This study is an exploratory one without a randomized control.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must provide voluntary informed consent and agree to comply with all protocol requirements.
- The subject must be at least 18 years of age on the date of informed consent form signing, with no restrictions based on gender.
- Expected survival duration of at least 12 weeks.
- Histopathologically confirmed recurrent or metastatic salivary gland cancer that cannot be treated with curative surgery or radiotherapy, including...
- Patients diagnosed with adenoid cystic carcinoma (ACC) or acinic cell carcinoma must meet one of the following criteria: evidence of radiographic...
You likely can't join if
- A history of other malignancies within the past five years is exclusionary, except for adequately treated and cured cervical carcinoma in situ...
- Prior receipt of any of the following treatments:
- Administration of an antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload within 3 months prior to first dose;
- Exposure to any investigational agent in a clinical trial within 28 days prior to first dose;
- Receipt of systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or other modalities) within 28 days prior to first...
- Undergone major surgery within 28 days prior to first dose without full recovery, or scheduled to undergo major surgery during the first 12 weeks...
See the full eligibility criteria
Who can join
- The subject must provide voluntary informed consent and agree to comply with all protocol requirements.
- The subject must be at least 18 years of age on the date of informed consent form signing, with no restrictions based on gender.
- Expected survival duration of at least 12 weeks.
- Histopathologically confirmed recurrent or metastatic salivary gland cancer that cannot be treated with curative surgery or radiotherapy, including major subtypes such as adenoid cystic carcinoma, mucoepidermoid...
- Patients diagnosed with adenoid cystic carcinoma (ACC) or acinic cell carcinoma must meet one of the following criteria: evidence of radiographic progression within 6 months prior to enrollment, or new or worsening...
- The subject must be able to provide a tumor tissue specimen-either from the primary or metastatic site-for pathological evaluation. Acceptable specimens include formalin-fixed paraffin-embedded blocks, paraffin-embedded...
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, the subject must have at least one measurable lesion at baseline, defined as a lesion with a longest diameter ≥10 mm on CT imaging (or...
- The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 within 7 days prior to the first administration of study drug.
- Organ function must meet the following criteria within 7 days prior to dosing:
- Hematologic function: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥90 g/L. people must not have received blood or platelet transfusions within 14 days prior to first dosing...
- Hepatic function: For patients without liver metastases, total serum bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. For patients...
- Coagulation function: International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Stable low-dose anticoagulation (e.g., aspirin 100 mg daily) is permitted.
- Renal function: Creatinine clearance (CrCl) ≥50 mL/min, calculated using the Cockcroft-Gault formula.
- Male people with reproductive potential and female people of childbearing potential must agree to use effective contraception from the time of informed consent through at least 6 months after the final dose of...
What rules you out
- A history of other malignancies within the past five years is exclusionary, except for adequately treated and cured cervical carcinoma in situ, thyroid cancer (excluding medullary or anaplastic types), or basal cell...
- Prior receipt of any of the following treatments:
- Administration of an antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload within 3 months prior to first dose;
- Exposure to any investigational agent in a clinical trial within 28 days prior to first dose;
- Receipt of systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or other modalities) within 28 days prior to first dose;
- Undergone major surgery within 28 days prior to first dose without full recovery, or scheduled to undergo major surgery during the first 12 weeks following initiation of study treatment.
- Patients with HER2-positive status at baseline who have not received HER2-targeted or combination therapy (including HER2 monoclonal antibody-based combinations, HER2 ADCs, or HER2-targeted small-molecule agents...
- Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal disease; or history of CNS metastasis treatment within 3 months prior to first dose.
- Clinically symptomatic pleural, peritoneal, or pericardial effusion requiring puncture drainage; except for patients with stable disease after symptomatic treatment, as determined by the investigator to be eligible for...
- Any severe or uncontrolled systemic illness, as determined by the investigator, including but not limited to poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg)...
- Poorly controlled cardiac disease, including heart failure of New York Heart Association (NYHA) class ≥2, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or...
- Active or uncontrolled infection, including:
- Hepatitis B virus (HBV): HBsAg positive and HBV DNA ≥2,000 IU/mL (with exclusion of drug-induced or other non-viral causes of hepatitis);
- Hepatitis C virus (HCV): anti-HCV antibody positive and detectable HCV RNA above the assay's lower limit of quantification;
- Human immunodeficiency virus (HIV) infection;
- Uncontrolled bacterial, viral (non-HBV/HCV), fungal, rickettsial, or parasitic infections, unless resolved with appropriate treatment prior to first administration of study drug.
- History of hypersensitivity to Ptoridimab or any excipient in MRG003 (histidine, histidine hydrochloride, sucrose, mannitol, polysorbate 80), or prior grade ≥3 hypersensitivity reaction to monoclonal antibodies or other...
- Known history of primary immunodeficiency or active autoimmune disease requiring immunosuppressive therapy; current or recent (within 2 weeks before enrollment) use of systemic immunosuppressants or corticosteroids at a...
- History of or concurrent moderate-to-severe interstitial lung disease, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm.
- Failure to recover from prior anti-cancer therapy-related toxicities to Grade ≤1 according to NCI-CTCAE v5.0, excluding alopecia, any degree of skin hyperpigmentation, or stable Grade 2 hypothyroidism on hormone...
- Peripheral neuropathy of Grade \>1.
- Any other condition that, in the investigator's judgment, contraindicates participation in the study, including substance abuse (e.g., alcoholism, drug addiction), or inability to comply with study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.