A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary

This is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC). \*\*Neoadjuvant Phase\*\* (3-week cycle, 2 cycles): * Putlimab (HX008): 200 mg, Q3W, D1, IV * Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV \*\*Adjuvant/Maintenance Phase:\*\* Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion. \*\*Group A (Postoperative pCR):\*\* * Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year * Adjuvant RT: 40 Gy/5 weeks \*\*Group B (Postoperative MPR):\*\* * Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year * Adjuvant RT: 50 Gy/5 weeks \*\*Group C (Postoperative Partial/No Response):\*\* * Low-risk (no extracapsular nodal extension \[ENE\] and negative margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60 Gy/6 weeks * High-risk (ENE and/or positive margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60-66 Gy/6-6.6 weeks + Cisplatin 60 mg/m², Q3W, D1, IV, for 2 cycles RT timing, field, and fractionation may be adjusted by investigators based on individual disease status. Imaging assessment every 2 cycles (±7 days) until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated.

Timeline

Start

2026-08-31

Primary completion

2028-01-31

Completion

2029-01-31

Drugs

Indications