Thyroid CancerPhase 2NCT07235566
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
A Phase 2 study testing MRG003 in combination with pucotenlimab in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 (a EGFR-ADC) in combination with pucotenlimab (a PD-1 inhibitor) for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- MRG003 in combination with pucotenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to Apr 2031
- 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
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Age ≥18 years on the day of signing the informed consent form, regardless of gender.
- Expected survival time ≥12 weeks.
- Patients with pathologically confirmed EGFR-positive ATC or PDTC, currently in a recurrent or metastatic stage and not eligible for curative resection. ATC/PDTC may coexist with differentiated thyroid cancer. EGFR positivity is defined as >10% of tumor cells showing positive immunohistochemical staining.
- For subjects with either BRAF V600E wild-type or mutant-type, treatment-naive patients or those who have previously received targeted therapy ± immunotherapy are eligible for enrollment. Regarding neoadjuvant/adjuvant therapy, if recurrence occurs within 6 months after completing neoadjuvant/adjuvant therapy, such treatment will be considered as systemic therapy for the recurrent/metastatic stage.
- Subjects must be able to provide tumor tissue specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic sites for pathological testing. The most recent archived tumor tissue specimen should be used. If archived tissue is unavailable, a new biopsy must be performed.
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- There must be radiographic evidence of disease progression during or after the most recent treatment, confirmed by the investigator. According to RECIST 1.1 criteria, there must be at least one measurable extracranial lesion at baseline. Measurable lesions should not have been irradiated, unless the lesion within a prior radiation field or after local treatment has demonstrated progression.
- Adverse events related to prior anti-tumor treatment have recovered to ≤ Grade 1 according to NCI CTCAE v5.0 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
- ECOG performance status of 0 or 1 within 7 days prior to treatment.
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to treatment.
- Organ function levels must meet the following requirements within 7 days prior to treatment.
- Fertile male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. A negative serum pregnancy test result within ≤7 days prior to the first dose of the study drug is required for women of childbearing potential.
Who cannot join
- Medullary thyroid carcinoma or other malignancies not originating from thyroid follicular cells;
- History of other primary malignancies; Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or patients who have received radical treatment and have had no recurrence within 5 years may participate in this trial;
- Received any of the following treatments:
- Prior treatment with an ADC drug;
- Treatment with an investigational drug from another clinical trial within 28 days prior to the first dose (excluding already marketed drugs);
- Treatment with anti-tumor Chinese patent medicines or herbal medicines within 14 days prior to the first dose;
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- Radiotherapy within 28 days prior to the first dose, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose;
- Major surgery within 28 days prior to the first dose without full recovery, or planned major surgery within the first 12 weeks after receiving the study drug.
- Untreated or unstable brain parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis, or leptomeningeal metastases; Note: Patients who have received local brain therapy may be enrolled if brain imaging shows stability for at least 28 days prior to the first dose, with no evidence of cerebral edema and no requirement for corticosteroid therapy.
- Presence of third-space fluid that cannot be controlled by methods such as drainage (e.g., massive ascites, pleural effusion, pericardial effusion, etc.), or subjects who required drainage to control third-space fluid within 14 days prior to dosing;
- Any severe or uncontrolled systemic disease, in the investigator's judgment, including poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), poorly controlled diabetes, signs of active bleeding, etc.;
- Poorly controlled cardiac disease, including heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmia requiring treatment, or long QT syndrome, such as QTcF > 450 ms (men) or QTcF > 470 ms (women);
- Evidence of active infection, including hepatitis B (requiring both HBsAg positivity and HBV DNA ≥2000 IU/ml, excluding hepatitis due to drugs or other causes), hepatitis C (requiring both anti-HCV antibody positivity and HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection; uncontrolled active bacterial, other viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to study drug administration;
- History of allergy to any component of pucotenlimab or MRG003 (histidine, histidine hydrochloride, sucrose, mannitol, and polysorbate 80), or history of ≥ Grade 3 allergy to macromolecular protein preparations/monoclonal antibodies;
- History of primary immunodeficiency or active autoimmune disease, currently using immunosuppressants or systemic hormonal therapy (at a dose ≥10 mg/day of prednisone or equivalent), and continuing use within 2 weeks prior to enrollment;
- Positive serum pregnancy test or lactating women who are unwilling to use adequate contraception during the study and for 6 months after the end of study drug treatment;
- Any other situation considered by the investigator as unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Phase II Clinical Trial Evaluating the Efficacy and Safety of MRG003 in Combination With Pucotenlimab for the Treatment of EGFR-positive Unresectable Locally Advanced or Metastatic ATC/PDTC
This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 (a EGFR-ADC) in combination with pucotenlimab (a PD-1 inhibitor) for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. All patients will receive the combination therapy every three weeks until disease progression or other event as defined in the protocol occurs.
Read the detailed description
This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 in combination with pucotenlimab for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. The trial will establish two cohorts based on the patient's BRAF V600E mutation status: Cohort 1 (BRAF V600E wild-type) or Cohort 2 (BRAF V600E mutant type). Each cohort will enroll approximately 30 evaluable subjects. After providing full informed consent and signing the informed consent form, eligible subjects will receive MRG003 2.0 mg/kg and Pucotenlimab 200 mg. Patients will receive the combination therapy every three weeks until a treatment discontinuation event as defined in the protocol occurs.
- Conditions
- Thyroid Cancer
- Being tested
- MRG003 in combination with pucotenlimab
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG003 in combination with pucotenlimabDrug
After providing full informed consent and signing the informed consent form, eligible subjects will receive MRG003 2.0 mg/kg and pucotenlimab 200 mg. Pucotenlimab will be administered intravenously on the first day of each treatment cycle (infusion time: 60 min ± 15 min; for the first cycle, the infusion time should not be less than 60 minutes). At least 30 minutes after the completion of the pucotenlimab infusion, MRG003 will be administered (infusion time: 60 min ± 15 min; for the first cycle, the infusion time should not be less than 60 minutes). Patients will receive the combination therapy every three weeks until a treatment discontinuation event as defined in the protocol occurs.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MRG003 in combination with pucotenlimab Receives: Drug: MRG003 in combination with pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate，ORR
Objective Response Rate (ORR) as assessed based on RECIST 1.1 criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start21 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235566
- Sponsor's protocol ID
- EPIC-TC
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Efficacy and Safety of MRG003 in Combination With Pucotenlimab for the Treatment of EGFR-positive Unresectable Locally Advanced or Metastatic ATC/PDTC
- ClinicalTrials.gov ID
- NCT07235566
- Acronym / sponsor ID
- EPIC-TC
- Conditions
- Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 (a EGFR-ADC) in combination with pucotenlimab (a PD-1 inhibitor) for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. All patients will receive the combination therapy every three weeks until disease progression or other event as defined in the protocol occurs.
Detailed description
This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 in combination with pucotenlimab for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. The trial will establish two cohorts based on the patient's BRAF V600E mutation status: Cohort 1 (BRAF V600E wild-type) or Cohort 2 (BRAF V600E mutant type). Each cohort will enroll approximately 30 evaluable subjects. After providing full informed consent and signing the informed consent form, eligible subjects will receive MRG003 2.0 mg/kg and Pucotenlimab 200 mg. Patients will receive the combination therapy every three weeks until a treatment discontinuation event as defined in the protocol occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MRG003 in combination with pucotenlimabMRG003 in combination with pucotenlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Age ≥18 years on the day of signing the informed consent form, regardless of gender.
- Expected survival time ≥12 weeks.
- Patients with pathologically confirmed EGFR-positive ATC or PDTC, currently in a recurrent or metastatic stage and not eligible for curative resection. ATC/PDTC may coexist with differentiated thyroid cancer. EGFR positivity is defined as >10% of tumor cells showing positive immunohistochemical staining.
- For subjects with either BRAF V600E wild-type or mutant-type, treatment-naive patients or those who have previously received targeted therapy ± immunotherapy are eligible for enrollment. Regarding neoadjuvant/adjuvant therapy, if recurrence occurs within 6 months after completing neoadjuvant/adjuvant therapy, such treatment will be considered as systemic therapy for the recurrent/metastatic stage.
Key exclusion criteria (17 listed)
- Medullary thyroid carcinoma or other malignancies not originating from thyroid follicular cells;
- History of other primary malignancies; Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or patients who have received radical treatment and have had no recurrence within 5 years may participate in this trial;
- Received any of the following treatments:
- Untreated or unstable brain parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis, or leptomeningeal metastases; Note: Patients who have received local brain therapy may be enrolled if brain imaging shows stability for at least 28 days prior to the first dose, with no evidence of cerebral edema and no requirement for corticosteroid therapy.
- Presence of third-space fluid that cannot be controlled by methods such as drainage (e.g., massive ascites, pleural effusion, pericardial effusion, etc.), or subjects who required drainage to control third-space fluid within 14 days prior to dosing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG003 in combination with pucotenlimabAfter providing full informed consent and signing the informed consent form, eligible subjects will receive MRG003 2.0 mg/kg and pucotenlimab 200 mg. Pucotenlimab will be administered intravenously on the first day of each treatment cycle (infusion time: 60 min ± 15 min; for the first cycle, the infusion time should not be less than 60 minutes). At least 30 minutes after the completion of the pucotenlimab infusion, MRG003 will be administered (infusion time: 60 min ± 15 min; for the first cycle, the infusion time should not be less than 60 minutes). Patients will receive the combination therapy every three weeks until a treatment discontinuation event as defined in the protocol occurs. | Drug | Treatment |
Primary outcome
Objective Response Rate，ORR
Time frame: 2 years
Objective Response Rate (ORR) as assessed based on RECIST 1.1 criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG003 in combination with pucotenlimab in people with Thyroid Cancer, run by Fudan University 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 12 inclusion and 17 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 19 Nov 2025. 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 Naisi Huang (86-021-64175590 ext. 67816, huangnaisi@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate，ORR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.