A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study
Eye & ENT Hospital of Fudan University
40 participants
May 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Age ≥ 18 years, male or female. Histopathologically confirmed primary sinonasal adenoid cystic carcinoma (SNACC) that is locally recurrent after prior surgery and/or radiotherapy.
- EGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.
- Multidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.
- At least one measurable lesion in the skull base/sinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.
- Willing to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.
Exclusion Criteria6
- Prior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.
- Prior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.
- Active uncontrolled infection, or active autoimmune disease requiring systemic therapy.
- Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.
- Known severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men/women planning to become pregnant within 6 months after the last dose of study treatment.
- Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.
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Interventions
Becotatug vedotin (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). It consists of a recombinant anti-EGFR humanized monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is administered intravenously at 2.0 mg/kg on day 1 of each 21-day cycle for 3 cycles. Epirubicin is an anthracycline chemotherapeutic agent that inhibits topoisomerase II, thereby interfering with DNA replication and transcription. It is administered intravenously at 75 mg/m² on day 1 of each 21-day cycle for 3 cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07522879