OncoMatch/Clinical Trials/NCT07235566
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
Is NCT07235566 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies MRG003 in combination with pucotenlimab for thyroid cancer.
Treatment: MRG003 in combination with pucotenlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Biomarker criteria
Required: EGFR overexpression (>10% of tumor cells positive by immunohistochemistry)
EGFR positivity is defined as >10% of tumor cells showing positive immunohistochemical staining
Allowed: BRAF V600E
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
Allowed: BRAF wild-type
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
Disease stage
Metastatic disease required
currently in a recurrent or metastatic stage and not eligible for curative resection; at least one measurable extracranial lesion at baseline per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antibody-drug conjugate
Prior treatment with an ADC drug
Cannot have received: investigational drug
Exception: excluding already marketed drugs
Treatment with an investigational drug from another clinical trial within 28 days prior to the first dose (excluding already marketed drugs)
Cannot have received: anti-tumor Chinese patent medicines or herbal medicines
Treatment with anti-tumor Chinese patent medicines or herbal medicines within 14 days prior to the first dose
Cannot have received: radiation therapy
Exception: palliative radiotherapy for bone metastases within 2 weeks prior to the first dose
Radiotherapy within 28 days prior to the first dose, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose
Cannot have received: major surgery
Exception: unless fully recovered; or planned major surgery within the first 12 weeks after receiving the study drug
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
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
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. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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