NCT07586124 Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT07586124 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lepu Biopharma Co., Ltd. |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-07-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-07-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07586124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07586124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07586124 currently recruiting?
Yes, NCT07586124 is actively recruiting participants. Contact the research team at ra_bj@lepubiopharma.com for enrollment information.
Where is the NCT07586124 trial being conducted?
This trial is being conducted at Beijing, China, Fuzhou, China, Guangzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07586124 clinical trial?
NCT07586124 is sponsored by Lepu Biopharma Co., Ltd.. The trial plans to enroll 80 participants.