Recruiting
Phase 2
Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
Condition(s) studied
Head and Neck Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
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
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)
- Major Pathological Response (MPR) Rate — From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Trial sites (15)
| Facility | City | Region | Status |
| 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 |
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