Becotatug vedotin plus epirubicin before surgery 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
This will test whether combining becotatug vedotin with epirubicin can shrink EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma enough to allow surgery or improve disease control.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07522879 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed recurrent sinonasal adenoid cystic carcinoma that is EGFR-positive by central IHC, judged unresectable by a multidisciplinary team, with at least one measurable lesion and ECOG performance status 0–1 are eligible.
Not a fit: Patients lacking EGFR expression, those with prior exposure to similar antibody‑drug conjugates, poor performance status, or widespread metastatic disease are unlikely to benefit from this neoadjuvant approach.
Why it matters
Potential benefit: If successful, the combination could shrink tumors enough to permit curative surgery or improve disease control for patients who currently have limited options.
How similar studies have performed: Antibody‑drug conjugates have shown activity in other solid tumors, but combining becotatug vedotin with epirubicin for EGFR-positive sinonasal adenoid cystic carcinoma is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 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 this trial is running
Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Quan Liu, Director
- Email: liuqent@163.com
- Phone: 8615001959681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.