Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials

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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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Life expectancy ≥ 6 months.

• Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.

• At least one extracranial measurable lesion per RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• No severe cardiac dysfunction.

• Must provide tumor tissue sample not previously subjected to radiotherapy.

• Adequate organ function.

• Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

Locations
Other Locations
China
Peking University Cancer Hospital
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
Liaoning Cancer Hospital & institute
NOT_YET_RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Program Director
ra_bj@lepubiopharma.com
86-21- 67680899
Time Frame
Start Date: 2026-07-06
Estimated Completion Date: 2028-12
Participants
Target number of participants: 80
Treatments
Experimental: locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Placebo_comparator: locally advanced resectable HNSCC Placebo +Pucotenlimab
Sponsors
Leads: Lepu Biopharma Co., Ltd.

This content was sourced from clinicaltrials.gov

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