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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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

Key facts

Study ID

NCT07586124

Run by

Lepu Biopharma Co., Ltd.

People needed

80

Starts

2026-07-06

Expected to finish

2028-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Life expectancy ≥ 6 months.
• Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
• At least one extracranial measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• No severe cardiac dysfunction.
• Must provide tumor tissue sample not previously subjected to radiotherapy.
• Adequate organ function.
• Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

You may not qualify if…

• Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
• Head and neck cancer deemed non-resectable by the investigator.
• Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
• Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.
• 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.
• Grade ≥2 peripheral neuropathy (CTCAE v5.0).
• Active autoimmune disease requiring systemic treatment within 2 years before first dose.
• Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.
• Radiologically detectable central nervous system metastases and/or carcinomatous meningitis.
• Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.
• Any severe or uncontrolled systemic disease.
• Prior or planned allogeneic tissue/solid organ transplantation.
• Known hypersensitivity to any active ingredient or excipient of the study drugs.
• Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Anti-infective therapy within 2 weeks before randomization.
• Stroke or transient ischemic attack within 6 months before enrollment.
• Uncontrolled or poorly controlled cardiac disease.
• Deep or intraluminal bleeding requiring interventional/surgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy.
• Pulmonary embolism or deep vein thrombosis within 3 months.
• History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc.
• Received live vaccine within 30 days before first study dose.
• History of other primary malignancy.
• Positive serum pregnancy test or breastfeeding female.
• Contraindications to study drugs (pucotenlimab and/or becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues.
• Any condition that the investigator considers unsuitable for participation in the trial.

Where it is running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, China
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Hubei Cancer Hospital — Wuhan, Hubei, China
• Xiangya Hospital of Central South University — Changsha, Hunan, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• Liaoning Cancer Hospital & institute — Shenyang, Liaoning, China
• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Peking University Cancer Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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