AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages 18 Years - anyAllLepu Biopharma Co., Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Life expectancy โ‰ฅ 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 โ‰ฅ2 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 โ‰ฅ3) to radiotherapy, cisplatin or its analogues. 25. Any condition that the investigator considers unsuitable for participation in the trial. 26. Grade โ‰ฅ2 hearing impairment per CTCAE v6.0.
๐Ÿ’Š

What it tests

  • Becotatug Vedotin for Injection
  • Placebo
  • Pucotenlimab Injection
๐Ÿ“

Where

15 sites
Peking University Cancer Hospital
Beijing, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Cancer Hospital of Shantou University Medical College
Shantou, China
Guangxi Medical University Cancer Hospital
Nanning, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Hubei Cancer Hospital
Wuhan, China

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy