NCT07235566

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	MRG003 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.

Timeline

• Start date: 2025-04-21
• Primary completion: 2029-04-01
• Completion: 2031-04-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: China