Actively Recruiting
A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
Led by Eye & ENT Hospital of Fudan University · Updated on 2026-05-12
40
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.
CONDITIONS
Official Title
A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically confirmed recurrent sinonasal adenoid cystic carcinoma after prior surgery and/or radiotherapy
- Positive EGFR expression by immunohistochemistry
- Tumor assessed by multidisciplinary team as not suitable for radical surgical removal
- At least one measurable tumor lesion in the skull base or sinonasal area of at least 10 mm
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, kidney, and heart function
- Willing and able to provide informed consent and comply with study procedures
You will not qualify if you...
- Prior treatment with any antibody-drug conjugate containing monomethyl auristatin E
- Chemotherapy with epirubicin or other anthracyclines within 6 months before enrollment
- Active uncontrolled infection or autoimmune disease needing systemic therapy
- Symptomatic or urgent central nervous system metastases needing immediate treatment
- Known severe allergy to study drugs
- Pregnant or breastfeeding women, or plans to become pregnant within 6 months after last study dose
- Any medical or psychosocial condition that may interfere with participation or increase risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
Q
Quan Liu, Director
CONTACT
W
Wanpeng Li, mid-level
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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