Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 8:40 AM
Study NCT ID:
NCT07235566
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: