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A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma

NCT07522879 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Adenoid Cystic Carcinoma
  • Sinonasal Carcinoma

Interventions

DRUG

Becotatug Vedotin

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.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-10-01
Completion
2030-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522879 on ClinicalTrials.gov