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

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT07522879
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Oct 1, 2028
Completion
Jul 1, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MRG003 + Epirubicin
    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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days). ]

Central Contacts

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