Clinical trial · Interventional
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
NCT07522879CI-TRIAL-00119523MRG003-SACCrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sinonasal Carcinoma | Sinonasal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Becotatug Vedotin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRG003 + Epirubicin
- description
- 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.
- interventionNames
- Drug: Becotatug Vedotin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).
- description
- Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.
Secondary outcomes (7)
- measure
- Safety and tolerability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- RESULTAgulnik 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
- RESULTVered 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
- RESULTZhou 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
- RESULTLupinetti 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
- RESULTMavrikios 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