RecruitingPhase 2NCT07814287

Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma

Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma: A Phase II Prospective Single-Arm Multicenter Trial

Sponsor

Xuekui Liu

Enrollment

40 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary

This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety. This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Becotatug Vedotin, Pucotenlimab, and Cisplatin for people with head and neck squamous cell carcinoma (hnscc). The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBecotatug Vedotin, Pucotenlimab, and Cisplatin

Becotatug vedotin is an EGFR-directed antibody-drug conjugate (ADC) comprising a humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. It binds to EGFR-overexpressing tumor cells, undergoes receptor-mediated internalization, and releases MMAE to inhibit microtubule polymerization, inducing cell cycle arrest and apoptosis. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody that blocks the PD-1/PD-L1 interaction, restoring T-cell-mediated antitumor immune responses. Cisplatin is a platinum-based alkylating agent that forms DNA crosslinks, leading to cell death. These three agents are administered as sequential intravenous infusions on Day 1 of each 21-day cycle: pucotenlimab 200 mg, followed by beccotatug vedotin 2.0 mg/kg, and cisplatin 60 mg/m². The regimen is given for up to 3 neoadjuvant cycles prior to definitive local therapy.