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AzTrials

Salivary Gland CarcinomasPhase 2TSEMPRMSGCNCT07464366

The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study

A Phase 2 study testing MRG 003 and Pucotenlimab in people with Salivary Gland Carcinomas, run by Ji Dongmei at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Salivary Gland Carcinomas
What is being tested?
MRG 003 and Pucotenlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
19 Mar 2026to 30 Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 carcinoma, and adenocarcinoma; and immunohistochemically confirmed EGFR expression or positivity.
  • 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 tumor-related symptoms.
  • 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 sections, or fresh tissue sections. If archived tissue is unavailable, a new biopsy must be performed.
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  • 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 a short axis ≥15 mm for lymph nodes). Lesions previously irradiated may be considered target lesions if there is radiological evidence of progression; however, non-irradiated lesions are preferred.
  • 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. Subjects must not have received blood or platelet transfusions within 14 days prior to first dosing, nor growth factor support (e.g., granulocyte colony-stimulating factor or erythropoiesis-stimulating agents) within 7 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 with liver metastases, TBIL ≤1.5 × ULN, and ALT and AST ≤5 × ULN.
  • 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 subjects with reproductive potential and female subjects 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 investigational product. Female subjects are considered of childbearing potential if they are premenopausal or within 2 years of menopause. A negative serum pregnancy test is required for all female subjects of childbearing potential within 7 days prior to the first administration of study drug.

Who cannot join

  • 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 carcinoma of the skin.
  • 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.
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  • 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; receipt of any one of these is acceptable for enrollment).
  • 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 enrollment.
  • 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), inadequately controlled diabetes mellitus, or evidence of active bleeding.
  • 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 ventricular arrhythmia requiring treatment.
  • 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 large protein therapeutics.
  • 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 dose equivalent to ≥10 mg/day prednisone.
  • Note: The following are permitted: type 1 diabetes mellitus with stable control; hypothyroidism managed with hormone replacement; vitiligo or psoriasis not requiring systemic therapy; use of topical or inhaled corticosteroids; or short-term (≤7 days) systemic corticosteroid use for non-autoimmune indications such as allergy prophylaxis or acute inflammation.
  • 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 replacement.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongmei Ji, Medical Doctor contact

+8613564183928

jid09@fudan.edu.cn

Guangliang Chen, Medical Doctor contact

+8618121299897

guangliang_chen@fudan.edu.cn

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dongmei Ji, Doctor, +86 02564175590 88900, jid09@fudan.edu.cn

    Guangliang Chen, Doctor, guangliang_chen@fudan.edu.cn

    Recruiting

Other trials in China

About this study

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. After fully informed and signing the informed consent form, eligible subjects will be enrolled in MRG003 treatment [Cohort 1 (ACC) and Cohort 2 (non-ACC SGCs) ] in the order of the study sequence. After the completion of enrollment in Cohort 1, subsequent eligible ACC subjects will be included in the MRG003 plus pertuzumab treatment (Cohort 3), and after the completion of enrollment in Cohort 2, subsequent eligible non-ACC SGC subjects will be included in the MRG003 plus pertuzumab treatment (Cohort 4). Patients in Cohort 1 and Cohort 2 will receive intravenous infusion of MRG003 on the first day of each treatment cycle at a dose of 2.3 mg/kg. Patients in Cohort 3 and Cohort 4 will receive intravenous infusion of pertuzumab on the first day of each treatment cycle at a dose of 3 mg/kg (up to a maximum of 200 mg), followed by MRG003 at a dose of 2.0 mg/kg at least 30 minutes after the completion of pertuzumab infusion. All patients will receive single-agent or combination therapy every three weeks until the end of two years of treatment or the occurrence of a treatment discontinuation event as specified in the protocol. After the treatment, safety follow-up and survival follow-up will be conducted for each subject. For subjects who end treatment due to reasons other than disease progression or death and have not started a new anti-tumor study, tumor imaging assessment will continue as originally planned until disease progression, initiation of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first. During the clinical study, we will establish PDX models for mechanism validation. In addition, it is recommended to analyze the following markers for subjects: IHC: ER, PR, AR, HER2, EGFR; FISH: HER2. Genetic testing is recommended based on the economic conditions of the subjects, but it is not mandatory. For subjects with HER2 3+ or HER2 2+ and FISH positive, it is recommended to receive anti-HER2 treatment first. For subjects who have undergone testing, we will collect the test results. For subjects who have not undergone testing, we will conduct relevant tests.

Being tested
MRG 003, Pucotenlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG 003Drug

    anti EGFR ADC

  • PucotenlimabDrug

    PD-1 inhibitor

Study groups in NCT07464366
Study groupRoleWhat they receive
MRG003 Monotherapy in ACCExperimentalMRG003 is administered intravenously at 2.3 mg/kg on day 1 of each cycle, every three weeks, as monotherapy, for up to two years or until treatment discontinuation criteria are met.
Receives: Drug: MRG 003
MRG003 combined with Pucontenlimab in ACCExperimentalMRG003 2.0 mg/kg combined with Pucontenlimab 3.0mg/kg ( ≤ 200mg) on day 1 of each cycle, every three weeks, for up to two years or until treatment discontinuation criteria are met.
Receives: Drug: MRG 003; Drug: Pucotenlimab
MRG003 Monotherapy in Non-ACC SGCExperimentalMRG003 is administered intravenously at 2.3 mg/kg on day 1 of each cycle, every three weeks, as monotherapy, for up to two years or until treatment discontinuation criteria are met.
Receives: Drug: MRG 003
MRG003 combined with Pucontenlimab in Non-ACC SGCExperimentalMRG003 2.0 mg/kg combined with Pucontenlimab 3.0mg/kg ( ≤ 200mg) on day 1 of each cycle, every three weeks, for up to two years or until treatment discontinuation criteria are met.
Receives: Drug: MRG 003; Drug: Pucotenlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The objective response rate (ORR) was evaluated by investigators using RECIST 1.1 criteria.

    The objective response rate (ORR) is defined as the proportion of subjects in whom the tumor has achieved either complete remission (CR) or partial remission (PR) following treatment.

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary outcomes (6)

  1. Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1 criteria

    The disease control rate (DCR) is defined as the proportion of subjects in the full analysis set (FAS) whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD) based on investigator assessment using RECIST v1.1. Subjects with SD must have maintained SD for at least 6 weeks from the first dose to be counted as disease control.

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  2. Duration of Response

    The time from the first documented evidence of objective response (CR or PR) to the first documented disease progression or death from any cause, whichever occurred first.

    Measured: From the date of the first objective response (according to Recist 1.1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  3. Progression-Free Survival

    The time from the first dose to the first documented disease progression as determined by investigator assessment according to RECIST v1.1, or death from any cause, whichever occurred first.

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  4. Overall survival

    The time from first dose to death from any cause.

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of death from any cause, assessed up to 60 months.

  5. Safety Assessments

    Adverse events (AEs) and serious adverse events (SAEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0). The incidence and severity of AEs and SAEs, as well as laboratory abnormalities, will be evaluated and summarized.

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date 30 days after last dose or the date of death, whichever occurs first, assessed up to 60 months.

  6. Dose Modification and Discontinuation Rates

    The following safety endpoints were evaluated:

    Rate of dose interruptions due to AEs Rate of dose reductions due to AEs Rate of treatment discontinuations due to AEs Incidence of deaths (including on-study deaths and deaths within 30 days of last dose)

    Measured: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date 30 days after last dose or the date of death, whichever occurs first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start19 Mar 2026
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07464366
Sponsor's protocol ID
FUSCC-SGC-001
Other IDs
FUSCC-SGC-001
Acronym
TSEMPRMSGC
Status last verified
Mar 2026
First submitted
30 Sep 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG 003 and Pucotenlimab in people with Salivary Gland Carcinomas, run by Ji Dongmei at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongmei Ji, Medical Doctor (+8613564183928, jid09@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective response rate (ORR) was evaluated by investigators using RECIST 1.1 criteria. (time frame: From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07464366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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