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NOT YET RECRUITING
NCT07844551
PHASE2

ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC/OPSCC

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Becotatug Vedotin (EGFR-targeted ADC, MRG003) plus Pucotenlimab (PD-1 inhibitor), compared with platinum-based chemotherapy/chemoradiotherapy, as an induction conversion regimen for downstaging primary stage IVB oral squamous cell carcinoma or HPV16-negative oropharyngeal squamous cell carcinoma.

Official title: Immunotherapy Combined With ADC (MRG003) for Induction Conversion Therapy to Downstage Primary Stage IVB Oral/Oropharyngeal Squamous Cell Carcinoma:An Exploratory Two-Arm Randomized Controlled Trial (Transforming Trial)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-20

Completion Date

2030-12-30

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin (MRG003)

2.3 mg/kg by intravenous infusion once every 21 days

DRUG

Pucotenlimab

200 mg by intravenous infusion once every 21 days

DRUG

Cisplatin

75mg/m2 by intravenous infusion once every 21 days