Head and Neck Squamous Cell CarcinomaPhase 2NCT07381075
A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Becotatug Vedotin, Becotatug Vedotin Combined with Penpulimab and Becotatug Vedotin Combined with Ivonescimab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Becotatug Vedotin, Becotatug Vedotin Combined with Penpulimab and Becotatug Vedotin Combined with Ivonescimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 31 Dec 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 70 years old, gender not restricted;
- Histopathologically diagnosed as squamous cell carcinoma of the head and neck (including oral cancer, laryngeal cancer, hypopharyngeal cancer, and oropharyngeal cancer, etc.);
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC);
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Have not received any treatment for head and neck squamous cell carcinoma before, including drug treatment, radiotherapy, surgical treatment, etc.;
- No distant metastasis;
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- The patient has the intention for radical treatment;
- Good hematopoietic function (total white blood cell count ≥ 3.0×109 /L, absolute lymphocyte count ≥ 0.8×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109 /L, hemoglobin ≥ 90g/L) and no blood transfusion or biological response modifiers (such as granulocyte growth factors, erythropoietin growth factors, etc.) treatment within 14 days before the first administration;
- Good liver function (total bilirubin (TBIL) ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5×ULN; serum albumin ≥ 28 g/L);
- Good renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula), urine protein less than 2+, or 24-hour urine protein quantification < 1g);
- Good cardiac function, that is, normal electrocardiogram or abnormal without clinical significance, and echocardiography shows left ventricular ejection fraction (left ventricular ejection fraction, LVEF) ≥ 50%;
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, if the subject is receiving anticoagulation treatment, as long as the PT is within the range of the anticoagulant drug plan, it is acceptable;
- During the screening period, blood pressure is well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg), and there is no change in antihypertensive treatment within 1 week before the first administration of the study drug;
- Patients with HBV infection who can detect HBV deoxyribonucleic acid (DNA) levels (≥ 10IU/mL or above the detection limit) must receive antiviral treatment before randomization according to the clinical institution practice to ensure adequate viral suppression. Patients must maintain antiviral treatment during the study and within 6 months after the last study treatment administration. Patients with positive Anti-HBc detection but no HBV DNA ( < 10IU/mL or below the detection limit) do not require antiviral treatment, unless HBV DNA exceeds 10IU/mL or above the detection limit during the treatment period;
- Male patients with fertility and women of childbearing age who are willing to take effective contraceptive measures from signing the informed consent form to the last administration of the study drug within 6 months; women of childbearing age include pre-menopausal women and post-menopausal women within 1 year. The blood pregnancy test result of women of childbearing age within ≤ 7 days before the first administration of the study drug must be negative;
- The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up.
Who cannot join
- Has received any form of anti-tumor treatment before;
- Patients with allergic constitution and congenital immune deficiency;
- Has undergone organ transplantation before;
- Has a history of severe bleeding tendency or coagulation dysfunction; had significant clinical bleeding symptoms within 1 month before the study treatment, including but not limited to gastrointestinal bleeding and hemoptysis; had continuous anticoagulation treatment within 10 days before the study treatment;
- Has experienced thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months before the study treatment;
- Has active autoimmune or inflammatory diseases, or has a related history, including inflammatory bowel disease (such as colitis or Crohn's disease), diverticulitis (except diverticular disease), systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome (such as granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitary inflammation and uveitis). There are the following exceptions: patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone replacement therapy (such as after Hashimoto's thyroiditis); any patients with chronic skin diseases that do not require systemic treatment; patients who can be included within the past 5 years without active diseases, but only after consultation with the study doctor;
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- Active infections, including tuberculosis or human immunodeficiency virus (HIV 1/2 antibody positive);
- Uncontrolled complications, including but not limited to: receiving study treatment for persistent or active infections (except HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, increase the risk of adverse events or affect the subject's ability to provide written informed consent;
- Pregnant or lactating women;
- The patient does not agree to use effective contraceptive measures during the treatment period and within the following 3 months;
- Patients participating in other clinical studies simultaneously;
- Patients with critical conditions unable to complete the survey;
- Other primary malignant tumor history, but the following situations are excluded: malignant tumors treated for curative purposes, and having no known active diseases for ≥ 5 years before the study treatment and a low potential risk of recurrence; fully treated non-melanoma skin cancer or benign lentigo-like nevus without evidence of disease; fully treated carcinoma in situ with no evidence of disease;
- Patients with a history of mental illness (such as schizophrenia, mania, anxiety disorder, depression, phobia, etc.) or patients diagnosed with mental illness during the clinical trial enrollment or their spouses;
- Patients with communication disorders due to confusion, aphasia, or intellectual disability caused by reasons such as communication barriers or inability to answer normally;
- Patients with other malignant tumor diseases;
- Has a ≥ 3-grade allergy history to any component of vebecotota monoclonal antibody and/or pannipil monoclonal antibody injection and/or ivosizumab monoclonal antibody injection;
- The investigator considers that there are other factors that are not suitable for inclusion or that may affect the subject's participation or completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West china hospital
Chengdu, Sichuan, 610000
Xiaoyuan Wei, PhD, 028-85422114, cqmuwxy@163.com
About this study
Official title: A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined With or Without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). This proposed study will evaluate the efficacy and safety of preoperative administration of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in LAHNSCC who are eligible for resection.
Read the detailed description
In this study, eligible patients will be randomized in a 1:1:1 ratio to either the Becotatug Vedotin treatment group (Cohort 1), or the Becotatug Vedotin combined with Penpulimab treatment group (Cohort 2), or the Becotatug Vedotin combined with Ivonescimab treatment group (Cohort 3). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Becotatug Vedotin, Becotatug Vedotin Combined with Penpulimab, Becotatug Vedotin Combined with Ivonescimab
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Neoadjuvant therapy, Antibody drug conjugate, Immunotherapy
- 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 VedotinDrug
Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1).
Becotatug Vedotin Combined with PenpulimabDrug
Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1).
Becotatug Vedotin Combined with IvonescimabDrug
Subjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1).
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin | Experimental | Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Receives: Drug: Becotatug Vedotin |
| Becotatug Vedotin Combined with Penpulimab | Experimental | Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1). Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Penpulimab treatment for 14 cycles following the completion of radiotherapy. Receives: Drug: Becotatug Vedotin Combined with Penpulimab |
| Becotatug Vedotin Combined with Ivonescimab | Experimental | Subjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Ivonescimab treatment for 14 cycles following the completion of radiotherapy. Receives: Drug: Becotatug Vedotin Combined with Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response rate
Measured: After surgery (approximately 9-10 weeks after start of study treatment)
Secondary outcomes (1)
MPR
major pathological remission
Measured: After surgery (approximately 9-10 weeks after start of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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 West China HospitalThe 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
- Model description
- A Randomized, Non-comparative Phase II Clinical Trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381075
- Sponsor's protocol ID
- MRG003-IIT-2026
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined With or Without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07381075
- Acronym / sponsor ID
- MRG003-IIT-2026
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Neoadjuvant therapy, Antibody drug conjugate, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Feb 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 Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). This proposed study will evaluate the efficacy and safety of preoperative administration of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in LAHNSCC who are eligible for resection.
Detailed description
In this study, eligible patients will be randomized in a 1:1:1 ratio to either the Becotatug Vedotin treatment group (Cohort 1), or the Becotatug Vedotin combined with Penpulimab treatment group (Cohort 2), or the Becotatug Vedotin combined with Ivonescimab treatment group (Cohort 3). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Randomized, Non-comparative Phase II Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin | Experimental | Drug: Becotatug VedotinSubjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. |
| Becotatug Vedotin Combined with Penpulimab | Experimental | Drug: Becotatug Vedotin Combined with PenpulimabSubjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1). Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Penpulimab treatment for 14 cycles following the completion of radiotherapy. |
| Becotatug Vedotin Combined with Ivonescimab | Experimental | Drug: Becotatug Vedotin Combined with IvonescimabSubjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Ivonescimab treatment for 14 cycles following the completion of radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: 18 - 70 years old, gender not restricted;
- Histopathologically diagnosed as squamous cell carcinoma of the head and neck (including oral cancer, laryngeal cancer, hypopharyngeal cancer, and oropharyngeal cancer, etc.);
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC);
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Have not received any treatment for head and neck squamous cell carcinoma before, including drug treatment, radiotherapy, surgical treatment, etc.;
Key exclusion criteria (18 listed)
- Has received any form of anti-tumor treatment before;
- Patients with allergic constitution and congenital immune deficiency;
- Has undergone organ transplantation before;
- Has a history of severe bleeding tendency or coagulation dysfunction; had significant clinical bleeding symptoms within 1 month before the study treatment, including but not limited to gastrointestinal bleeding and hemoptysis; had continuous anticoagulation treatment within 10 days before the study treatment;
- Has experienced thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months before the study treatment;
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 VedotinSubjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1). | Drug | Becotatug Vedotin |
| Becotatug Vedotin Combined with PenpulimabSubjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1). | Drug | Becotatug Vedotin Combined with Penpulimab |
| Becotatug Vedotin Combined with IvonescimabSubjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1). | Drug | Becotatug Vedotin Combined with Ivonescimab |
Primary outcome
pCR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
Pathological complete response rate
1 secondary outcome
MPR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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, Becotatug Vedotin Combined with Penpulimab and Becotatug Vedotin Combined with Ivonescimab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site 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 16 inclusion and 18 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Lei Liu (+86 189 8060 6231, liuleihx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: After surgery (approximately 9-10 weeks after start of study treatment)). 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 11 Sep 2026.