New drug cocktail aims to boost head and neck cancer surgery success

NCT ID NCT07586124

Disease control Sponsor: Lepu Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This phase II trial tests whether combining two drugs—pucotenlimab (an immunotherapy) and becotatug vedotin (a targeted chemotherapy)—given before and after surgery can improve outcomes for people with locally advanced head and neck cancer. About 80 participants will receive either the drug combo or a placebo alongside standard surgery. The main goal is to see if the treatment increases the number of patients whose tumors shrink significantly or disappear completely before surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: pucotenlimab and becotatug vedotin
What this could lead to: If successful, this combination could shrink tumors before surgery, potentially improving survival and reducing recurrence in head and neck cancer patients.
What could go wrong: This is an early phase II trial with only 80 participants, so results may not apply broadly. The drugs may cause side effects like immune reactions or nerve damage, and the combination might not work better than standard care.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

15 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING

Shantou, Guangdong, 515041, China
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING

Nanning, Guangxi, 530021, China
Hubei Cancer Hospital
NOT_YET_RECRUITING

Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
NOT_YET_RECRUITING

Changsha, Hunan, 410013, China
Liaoning Cancer Hospital & institute
NOT_YET_RECRUITING

Shenyang, Liaoning, 110042, China
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315040, China
Peking University Cancer Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100142, China
Shanghai East Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200120, China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200011, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING

Guangzhou, Guangdong, 510120, China
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING

Fuzhou, Fujian, 350005, China
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING

Shijiazhuang, Hebei, 050011, China
Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410008, China
Zhejiang Cancer Hospital
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310022, China

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