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

Sponsor
Fudan University
Study ID
NCT07235566
Phase
PHASE2
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRG003 in combination with pucotenlimab — DRUG
    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 Details

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.

Key Dates

First listed
Nov 19, 2025
Start date
Apr 21, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    MRG003 in combination with pucotenlimab

Primary Outcome Measure

Objective Response Rate，ORR [ Time Frame: 2 years ]

Central Contacts

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