Trials Sponsors Conditions Drugs Pricing

Brief 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). 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.

Conditions

Salivary Gland Carcinomas

Outcome Measures

Primary Outcomes (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.
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)

Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1 criteria
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.
Duration of Response
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.
Progression-Free Survival
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.
Overall survival
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.
Safety Assessments
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.

Study Arms (4)

MRG003 Monotherapy in ACC

EXPERIMENTAL

MRG003 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.

Drug: MRG 003

MRG003 combined with Pucontenlimab in ACC

EXPERIMENTAL

MRG003 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.

Drug: MRG 003Drug: Pucotenlimab

MRG003 Monotherapy in Non-ACC SGC

EXPERIMENTAL

Interventions

MRG 003Drug

anti EGFR ADC

MRG003 Monotherapy in ACCMRG003 Monotherapy in Non-ACC SGCMRG003 combined with Pucontenlimab in ACCMRG003 combined with Pucontenlimab in Non-ACC SGC

PucotenlimabDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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.

Sponsors & Collaborators

Ji Dongmei
Otherlead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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

Guangliang Chen, DoctorCONTACTguangliang_chen@fudan.edu.cn

Central Study Contacts

Dongmei Ji, Medical Doctor

CONTACT

+8613564183928 jid09@fudan.edu.cn

Guangliang Chen, Medical Doctor

CONTACT

+8618121299897

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: professor

Study Record Dates

First Submitted

September 30, 2025

First Posted

March 11, 2026

Study Start

March 19, 2026

Actual (reported)

Primary Completion

May 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

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; 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 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.
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (4)

MRG003 Monotherapy in ACC

MRG003 combined with Pucontenlimab in ACC

MRG003 Monotherapy in Non-ACC SGC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

MRG003 combined with Pucontenlimab in Non-ACC SGC

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (4)

MRG003 Monotherapy in ACC

MRG003 combined with Pucontenlimab in ACC

MRG003 Monotherapy in Non-ACC SGC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

MRG003 combined with Pucontenlimab in Non-ACC SGC

You may not qualify if:

Source record

Locations