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

NCT07522879 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FudanENT-2026041-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

EGFR protein; Unresectable; Adenoid cystic carcinoma; Sinonasal; Becotatug vedotin; Epirubicin; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.

  21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).

Secondary Outcomes (7)

• Safety and tolerability

  From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).

• Surgical conversion rate

  Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).

• Disease control rate (DCR)

  21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.

• R0 resection rate

  At time of surgery (within 4 weeks after neoadjuvant therapy completion).

• Pathologic response rate

  At time of surgery (within 4 weeks after neoadjuvant therapy completion).

Study Arms (1)

MRG003 + Epirubicin

EXPERIMENTAL

Participants receive MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on day 1 plus epirubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 3 cycles.

Drug: Becotatug Vedotin

Interventions

Becotatug Vedotin DRUG

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.

MRG003 + Epirubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Related Publications (5)

• Agulnik M, Cohen EW, Cohen RB, Chen EX, Vokes EE, Hotte SJ, Winquist E, Laurie S, Hayes DN, Dancey JE, Brown S, Pond GR, Lorimer I, Daneshmand M, Ho J, Tsao MS, Siu LL. Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. J Clin Oncol. 2007 Sep 1;25(25):3978-84. doi: 10.1200/JCO.2007.11.8612.

  PMID: 17761983 RESULT

• Vered M, Braunstein E, Buchner A. Immunohistochemical study of epidermal growth factor receptor in adenoid cystic carcinoma of salivary gland origin. Head Neck. 2002 Jul;24(7):632-6. doi: 10.1002/hed.10104.

  PMID: 12112535 RESULT

• Zhou J, Zhao G, Wang S, Li N. Systemic therapy in the management of metastatic or locally recurrent adenoid cystic carcinoma of the salivary glands: a systematic review of the last decade. Br J Cancer. 2024 Oct;131(6):1021-1031. doi: 10.1038/s41416-024-02795-4. Epub 2024 Aug 3.

  PMID: 39097677 RESULT

• Lupinetti AD, Roberts DB, Williams MD, Kupferman ME, Rosenthal DI, Demonte F, El-Naggar A, Weber RS, Hanna EY. Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience. Cancer. 2007 Dec 15;110(12):2726-31. doi: 10.1002/cncr.23096.

  PMID: 17960615 RESULT

• Mavrikios A, Goudjil F, Beddok A, Zefkili S, Bolle S, Feuvret L, Le Tourneau C, Choussy O, Sauvaget E, Herman P, Dendale R, Calugaru V. Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature. Head Neck. 2023 Jul;45(7):1619-1631. doi: 10.1002/hed.27371. Epub 2023 Apr 25.

  PMID: 37097003 RESULT

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Quan Liu, Director

CONTACT

8615001959681; liuqent@163.com

Wanpeng Li, mid-level

CONTACT

8613262856870; 18879117831@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share