Becotatug vedotin plus epirubicin before surgery for EGFR-positive unresectable recurrent sinonasal adenoid cystic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, open-label phase II neoadjuvant trial enrolling about 40 patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma. Participants receive three 21-day cycles of becotatug vedotin (MRG003) 2.0 mg/kg IV on day 1 plus epirubicin 75 mg/m² IV on day 1, with response assessed by RECIST v1.1 about 21 days after the third cycle. The primary endpoint is objective response rate (ORR); secondary endpoints include safety, surgical conversion and resection rates, pathological response, disease control, PFS, and OS. A translational sub-study will attempt to build patient-derived organoids from pre-treatment biopsies to explore biomarkers and treatment sensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥ 18 years, male or female. Histopathologically confirmed sinonasal adenoid cystic carcinoma (SNACC) with measurable recurrent disease located in the sinonasal/skull base region, irrespective of the presence of regional lymph node or distant metastases.

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 Criteria:

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.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Quan Liu, Director
• Email: liuqent@163.com
• Phone: 8615001959681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.