Head and Neck Squamous Cell CarcinomaPhase 2NCT07586124
Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Becotatug Vedotin for Injection and Pucotenlimab Injection in people with Head and Neck Squamous Cell Carcinoma, run by Lepu Biopharma Co., Ltd. at 15 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Becotatug Vedotin for Injection and Pucotenlimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 15 sitesChina
- Study dates
- 6 Jul 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Grade ≥2 hearing impairment per CTCAE v6.0.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Bin Zhang
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Canhua Jiang
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Hao Tian
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Gongbiao Lin
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xuekui Liu
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Jinsong Li
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Chao Chen
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Duoping Wang
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315040
Zhisen Shen
- Not yet recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Yue He
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Ye Guo
- Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Hanwei Peng
- Not yet recruiting
Liaoning Cancer Hospital & institute
Shenyang, Liaoning, 110042
Zhendong Li
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Juan Li
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Jian Chen
About this study
Official title: A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
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
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Becotatug Vedotin for Injection, Placebo, Pucotenlimab Injection
- Keywords
- Pucotenlimab, Becotatug Vedotin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin for InjectionDrug
Administrated intravenously
PlaceboDrug
Administrated intravenously
Pucotenlimab InjectionDrug
Administrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab | Experimental | Not described Receives: Drug: Becotatug Vedotin for Injection; Drug: Pucotenlimab Injection |
| locally advanced resectable HNSCC Placebo +Pucotenlimab | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Pucotenlimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
Measured: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Secondary outcomes (10)
Pathological Complete Response (pCR) Rate
Measured: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Event-Free Survival (EFS)
Measured: From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Measured: From date of randomization until death from any cause, assessed up to 36 months
Preoperative Objective Response Rate (ORR)
Measured: preoperative ORR will be assessed up to 12 weeks post-randomization
actual surgical resection rate
Measured: surgical resection rate will be evaluated perioperatively
R0 resection rate
Measured: R0 resection rate will be confirmed up to 8 weeks postoperatively
lymph node downstaging rate
Measured: lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
Incidence of adverse events (AEs) and laboratory abnormalities assessed by CTCAE v6.0
Measured: Within 30 days after last dose (30 days + 7 days window)
Serum Concentration
Measured: From randomization through completion of therapy, up to 30 weeks
Incidence of Anti-Drug Antibodies (ADA)
Measured: From randomization through completion of therapy, up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start6 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Lepu Biopharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586124
- Sponsor's protocol ID
- HX008/MRG003-C004
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07586124
- Acronym / sponsor ID
- HX008/MRG003-C004
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Pucotenlimab, Becotatug Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lepu Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab | Experimental | Drug: Becotatug Vedotin for Injection, Drug: Pucotenlimab Injection |
| locally advanced resectable HNSCC Placebo +Pucotenlimab | Placebo comparator | Drug: Placebo, Drug: Pucotenlimab Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug Vedotin for InjectionAdministrated intravenously | Drug | locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab |
| PlaceboAdministrated intravenously | Drug | locally advanced resectable HNSCC Placebo +Pucotenlimab |
| Pucotenlimab InjectionAdministrated intravenously | Drug | locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab, locally advanced resectable HNSCC Placebo +Pucotenlimab |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
10 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Event-Free Survival (EFS)
Time frame: From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Time frame: From date of randomization until death from any cause, assessed up to 36 months
Preoperative Objective Response Rate (ORR)
Time frame: preoperative ORR will be assessed up to 12 weeks post-randomization
actual surgical resection rate
Time frame: surgical resection rate will be evaluated perioperatively
R0 resection rate
Time frame: R0 resection rate will be confirmed up to 8 weeks postoperatively
lymph node downstaging rate
Time frame: lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
Incidence of adverse events (AEs) and laboratory abnormalities assessed by CTCAE v6.0
Time frame: Within 30 days after last dose (30 days + 7 days window)
Serum Concentration
Time frame: From randomization through completion of therapy, up to 30 weeks
Incidence of Anti-Drug Antibodies (ADA)
Time frame: From randomization through completion of therapy, up to 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin for Injection and Pucotenlimab Injection in people with Head and Neck Squamous Cell Carcinoma, run by Lepu Biopharma Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21- 67680899, ra_bj@lepubiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.