Actively Recruiting
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
Led by Fudan University · Updated on 2025-11-19
60
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Age 18 years or older at the time of signing the informed consent.
- Expected survival time of at least 12 weeks.
- Pathologically confirmed EGFR-positive anaplastic thyroid cancer (ATC) or poorly differentiated thyroid cancer (PDTC) in recurrent or metastatic stage, not eligible for curative surgery.
- EGFR positivity defined as more than 10% tumor cells positive by immunohistochemical staining.
- Patients can be treatment-naive or have received prior targeted therapy and/or immunotherapy.
- Ability to provide tumor tissue samples for pathological testing.
- Radiographic evidence of disease progression with at least one measurable extracranial lesion at baseline per RECIST 1.1.
- Recovery from prior anti-tumor treatment adverse events to grade 1 or less (except alopecia and non-significant lab abnormalities).
- ECOG performance status of 0 or 1 within 7 days prior to treatment.
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days prior to treatment.
- Adequate organ function within 7 days prior to treatment.
- Agree to use effective contraception from signing consent until 6 months after last study drug dose if of childbearing potential.
- Negative serum pregnancy test within 7 days before first study drug dose for women of childbearing potential.
You will not qualify if you...
- Medullary thyroid carcinoma or other non-thyroid follicular cell cancers.
- History of other primary cancers except certain skin or superficial bladder cancers treated with no recurrence for 5 years.
- Prior treatment with ADC drugs.
- Treatment with investigational drugs within 28 days prior to first dose, excluding marketed drugs.
- Use of anti-tumor Chinese patent or herbal medicines within 14 days prior to first dose.
- Radiotherapy within 28 days prior to first dose or palliative radiotherapy for bone metastases within 14 days prior.
- Major surgery within 28 days prior to first dose without full recovery or planned major surgery within 12 weeks after study drug.
- Untreated or unstable brain metastases or related CNS conditions.
- Uncontrolled third-space fluid requiring drainage within 14 days prior to dosing.
- Severe or uncontrolled systemic diseases including poorly controlled hypertension or diabetes.
- Poorly controlled cardiac disease or significant arrhythmias.
- Active infections including hepatitis B or C, HIV, or uncontrolled bacterial/viral/fungal/parasitic infections.
- Allergy to any components of pucotenlimab or MRG003 or severe allergy to related proteins.
- History of primary immunodeficiency or active autoimmune disease requiring immunosuppressants or systemic steroids.
- Positive pregnancy test or unwillingness to use contraception during and 6 months after treatment.
- Any other condition deemed unsuitable by the investigator for participation in the trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
N
Naisi Huang
CONTACT
Y
Yu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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