RecruitingPhase 2NCT07235566

MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC

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

Sponsor

Fudan University

Enrollment

60 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Thyroid Cancer

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. All patients will receive the combination therapy every three weeks until disease progression or other event as defined in the protocol occurs.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted treatments — MRG003 (an antibody-drug conjugate that targets a protein called EGFR) and pucotenlimab (an immunotherapy) — in people with an aggressive type of thyroid cancer (anaplastic thyroid cancer or poorly differentiated thyroid cancer) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have confirmed EGFR-positive anaplastic or poorly differentiated thyroid cancer that has spread or come back - You are not a candidate for curative surgery - Your expected survival is at least 12 weeks - You may be treatment-naive or have had prior targeted therapy or immunotherapy **You may NOT be eligible if...** - Your thyroid cancer does not express the EGFR protein - You have other serious health conditions preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMRG003 in combination with pucotenlimab

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.