NCT07393477

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma

Efficacy and Safety Profile of Becotatug Vedotin(EGFR-Targeting ADC) in Combination With Pucotenlimab and Cisplatin as Neoadjuvant Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy. Main Questions This Trial Aims to Answer: 1. Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)? 2. What are the safety and tolerability profiles of the combination therapy? 3. Does the treatment improve disease-free survival at 1 year after treatment? What Participants Will Do: Treatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting. Treatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen. Follow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy. Outcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma HNSCC

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin	Neoadjuvant therapy: Becotatug Vedotin 2.0mg/kg + Pucotenlimab 200mg + Cisplatin 75mg/m2, all administered via intravenous infusion on Day 1 (d1), with a 21-day treatment cycle for a total of 2-4 cycles (the exact number of cycles is determined by the investigator based on imaging findings, laryngoscopy results, etc.)

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-07-01
• Completion: 2029-05-01
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China