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RECRUITING
NCT07586124
PHASE2

Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

Sponsor: Lepu Biopharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma

Official title: A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07-06

Completion Date

2028-12

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin for Injection

Administrated intravenously

DRUG

Placebo

Administrated intravenously

DRUG

Pucotenlimab Injection

Administrated intravenously

Locations (15)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Liaoning Cancer Hospital & institute

Shenyang, Liaoning, China

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China