Pucotenlimab plus Becotatug Vedotin in locally advanced resectable head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized phase II trial compares Becotatug Vedotin with PD-1 inhibitor Pucotenlimab versus control in patients with locally advanced, resectable head and neck squamous cell carcinoma. The study aims to assess safety, pharmacokinetics, and preliminary efficacy as part of perioperative treatment. Eligible patients have resectable Stage III–IVA disease, measurable tumors, good performance status, and adequate organ function. Exclusions include non-squamous primary sites, non-resectable disease, and prior PD-1/PD-L1 or ADC therapies. The trial is led by Lepu Biopharma with sites in Beijing, Fuzhou, and Guangzhou.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• Cancer Hospital of Shantou University Medical College
  Shantou, Guangdong, China Not yet recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, Guangxi, China Not yet recruiting

Study contacts

• Study coordinator: Program Director
• Email: ra_bj@lepubiopharma.com
• Phone: 86-21- 67680899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• Pucotenlimab and Anlotinib with Chemo Before Surgery for Early-Stage Triple-Negative Breast Cancer

  This study tests a combo of pucotenlimab, anlotinib, and nab-paclitaxel before surgery in adults with newly diagnosed, stage II-III triple-negative breast cancer that is PD-L1 known.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou · NCT07896668

• Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer

  This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07884188

• ICG with near-infrared imaging to visualize head and neck cancer during surgery

  This study tests whether first-window indocyanine green fluorescence seen during surgery matches the cancer extent seen on pathology in patients with head and neck squamous cell carcinoma.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07825597

• Triple-drug neoadjuvant therapy for EGFR-positive locally advanced head and neck cancer

  This trial tests a three-drug neoadjuvant regimen (Becotatug Vedotin, Pucotenlimab, and Cisplatin) in adults with EGFR-positive, locally advanced head and neck cancer to see if it can shrink tumors before surgery or chemoradiotherapy.

  Recruiting at 2 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT07814287

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.