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NOT YET RECRUITING
NCT07589049
PHASE2

Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, multi-center, Phase II clinical trial evaluating the efficacy and safety of neoadjuvant becotatug vedotin (an anti-EGFR antibody-drug conjugate) combined with pucotenlimab (HX008, an anti-PD-1 monoclonal antibody) in patients with resectable recurrent head and neck squamous cell carcinoma (rHNSCC) who have progressed on prior PD-1/PD-L1 inhibitor and platinum-based therapy. A total of 42 EGFR-positive patients will be enrolled using Simon's two-stage design across 11 centers in China (Stage 1: 25 patients; Stage 2: 17 additional patients with 5% dropout). Enrolled patients will receive 3 cycles of neoadjuvant becotatug vedotin (2.3 mg/kg, IV, Q3W) plus pucotenlimab (3 mg/kg, IV, Q3W), followed by salvage surgery (3-4 weeks later), adjuvant radiotherapy +/- chemotherapy per NCCN/CSCO guidelines, and pucotenlimab maintenance therapy (3 mg/kg, Q3W) for up to 12 cycles or until disease progression or unacceptable toxicity. The primary endpoint is major pathological response (MPR) rate. The null hypothesis MPR rate is 14% (historical data) and the target MPR rate is 30% (alpha=0.05, power=0.8, one-sided). Secondary endpoints include objective response rate (ORR), pathological complete response (pCR), survival outcomes, quality of life, and safety.

Official title: Neoadjuvant Becotatug Vedotin (Anti-EGFR ADC) Combined With Pucotenlimab (Anti-PD-1) in Patients With Resectable Recurrent Head and Neck Squamous Cell Carcinoma Who Progressed on Prior PD-1/PD-L1 Inhibitor and Platinum-Based Therapy: A Prospective, Single-Arm, Multi-Center, Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-05

Completion Date

2029-05

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin

Becotatug vedotin as one of the drugs used in neoadjuvant therapy.

DRUG

Pucotenlimab

Pucotenlimab as one of the drugs used in neoadjuvant therapy.

Locations (12)

The First People's Hospital of Foshan

Foshan, Guangdong, China

Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China