🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07586124
Recruiting Phase 2

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

NCT07586124 · tracked via the Priya Life Science China tracker
Sponsor
Lepu Biopharma Co., Ltd.
Phase
Phase 2
Started
2026-07-06
Last updated
2026-07-09

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Becotatug Vedotin for InjectionPlaceboPucotenlimab Injection

Becotatug Vedotin for Injection: Administrated intravenously

Placebo: Administrated intravenously

Pucotenlimab Injection: Administrated intravenously

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Life expectancy ≥ 6 months. 2. Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery. 3. At least one extracranial measurable lesion per RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. No severe cardiac dysfunction. 6. Must provide tumor tissue sample not previously subjected to radiotherapy. 7. Adequate organ function. 8. Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose. Exclusion Criteria: 1. Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma). 2. Head and neck cancer deemed non-resectable by the investigator. 3. Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors. 4. Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry. 5. Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities/complications. Minor procedures (e.g., vascular access placement, percutaneous/endoscopic head/neck biopsy, tracheostomy tube exchange) are allowed. 6. Grade ≥2 peripheral neuropathy (CTCAE v5.0). 7. Active autoimmune disease requiring systemic treatment within 2 years before first dose. 8. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose. 9. Radiologically detectable central nervous system metastases and/or carcinomatous meningitis. 10. Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion. 11. Any severe or uncontrolled systemic disease. 12. Prior or planned allogeneic tissue/solid organ transplantation. 13. Known hypersensitivity to any active ingredient or excipient of the study drugs. 14. Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). 15. Anti-infective therapy within 2 weeks before randomization. 16. Stroke or transient ischemic attack within 6 months before enrollment. 17. Uncontrolled or poorly controlled cardiac disease. 18. Deep or intraluminal bleeding requiring interventional/surgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy. 19. Pulmonary embolism or deep vein thrombosis within 3 months. 20. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc. 21. Received live vaccine within 30 days before first study dose. 22. History of other primary malignancy. 23. Positive serum pregnancy test or breastfeeding female. 24. Contraindications to study drugs (pucotenlimab and/or becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues. 25. Any condition that the investigator considers unsuitable for participation in the trial. 26. Grade ≥2 hearing impairment per CTCAE v6.0.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Cancer Hospital of Shantou University Medical College Shantou Guangdong Not Yet Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
Liaoning Cancer Hospital & institute Shenyang Liaoning Not Yet Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Not Yet Recruiting
Ningbo Medical Center Lihuili Hospital Ningbo Zhejiang Not Yet Recruiting

More Lepu Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586124 on ClinicalTrials.gov ↗ ← All trials in China