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

ConditionsAdenoid Cystic CarcinomaSinonasal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: MRG003 + EpirubicinExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Safety and tolerability

Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0.

Time frame
From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).
2

Surgical conversion rate

Proportion of participants who undergo radical surgery (R0 or R1 resection) after neoadjuvant therapy, as assessed by multidisciplinary team (MDT).

Time frame
Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).
3

Disease control rate (DCR)

Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.

Time frame
21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.
4

R0 resection rate

Among participants who undergo surgery, proportion with negative microscopic margins (R0) on final histopathology.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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