A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Po… (NCT07522879) | Clinical Trial Compass
RecruitingPhase 2
A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
China40 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).