Head and Neck Squamous Cell CarcinomaPhase 2NCT07393477
Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma HNSCC, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). 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, Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to May 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
- Aged 18-70 years (inclusive).
- Histopathologically confirmed Stage III/IVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual).
- Measurable primary lesions per RECIST v1.1.
- Treatment-naive (no prior anti-tumor therapy for current disease).
- ECOG performance status 0-1.
- Eligible for elective standard surgery plus adjuvant chemoradiotherapy/radiotherapy (investigator-assessed).
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- No active autoimmune diseases.
- No concurrent malignant tumors.
- Estimated life expectancy >= 6 months.
- Available tumor tissue for PD-L1 IHC testing (22C3 DAKO assay).
- Adequate hematological function (screening): ANC >= 1.5×10⁹/L, platelets >= 100×10⁹/L, Hb >= 100 g/L, WBC >= 3.5×10⁹/L; no blood transfusion or bleeding tendency within 7 days.
- Normal liver function: ALT, AST, ALP, serum bilirubin <= 1.5×ULN.
- Normal renal function: Serum Cr <= 1.5×ULN or creatinine clearance > 60 mL/min.
- HPV status confirmed by p16 IHC and in situ hybridization (ISH).
- Voluntary participation with signed informed consent; legal guardian-signed consent for incompetent subjects, and witness-supervised consent for illiterate subjects.
Who cannot join
- Cachexia or multiple organ failure.
- Active autoimmune disease of any type.
- Concomitant second primary malignancy (e.g., esophageal cancer).
- Severe active infection requiring systemic therapy.
- Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart/cerebrovascular disease, uncontrolled diabetes/hypertension, active peptic ulcer).
- Dementia, altered mental status, or other conditions impairing informed consent or questionnaire completion.
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- Peripheral neuropathy >= Grade 2 per CTCAE v5.0.
- Hearing impairment >= Grade 2 per CTCAE v5.0.
- History of malignancy within 5 years prior to screening.
- Known HIV-positive status or diagnosed AIDS.
- Nasopharyngeal carcinoma or HNSCC at sites other than oral cavity, oropharynx, larynx, hypopharynx (e.g., paranasal sinuses, unknown primary).
- Receipt of investigational drugs or participation in other interventional trials within 30 days prior to screening.
- Systemic glucocorticoids (>10 mg prednisone equivalent/day) or other immunosuppressants within 14 days prior to randomization (inhaled/topical steroids and adrenal hormone replacement are permitted without active autoimmune disease).
- Pregnant/lactating women; subjects of childbearing potential refusing contraception.
- Active infection requiring treatment or systemic anti-infective use within 1 week prior to first dose.
- Live vaccine administration within 30 days prior to first dose.
- Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill status).
- Other conditions deemed unsuitable for enrollment by the investigator.
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
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jie Qi, +86 159 6814 8663, 562322092@qq.com
About this study
Official title: Efficacy and Safety Profile of Becotatug Vedotin(EGFR-Targeting ADC) in Combination With Pucotenlimab and Cisplatin as Neoadjuvant Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
The primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy.
Read more
Main Questions This Trial Aims to Answer:
- Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)?
- What are the safety and tolerability profiles of the combination therapy?
- Does the treatment improve disease-free survival at 1 year after treatment?
What Participants Will Do:
Treatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting.
Treatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen.
Follow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy.
Outcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.
- Being tested
- Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin
- 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.
Combination Therapy with Becotatug Vedotin, Pucotenlimab, and CisplatinCombination product
Neoadjuvant therapy: Becotatug Vedotin 2.0mg/kg + Pucotenlimab 200mg + Cisplatin 75mg/m2, all administered via intravenous infusion on Day 1 (d1), with a 21-day treatment cycle for a total of 2-4 cycles (the exact number of cycles is determined by the investigator based on imaging findings, laryngoscopy results, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin | Experimental | Participants in this arm will receive a combination of Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab (PD-1 Inhibitor), and Cisplatin as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The treatment will be administered for approximately 6-12 weeks, followed by surgery. Participants will be monitored for safety and efficacy through routine check-ups and pathological assessments. Receives: Combination Product: Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response(pCR) Rate
Measured: Within 7 weeks after the completion of neoadjuvant therapy
Secondary outcomes (2)
Major Pathological Response(MPR) Rate
Measured: Within 7 weeks after the completion of neoadjuvant therapy
1-Year Disease-Free Survival
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionMay 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393477
- Sponsor's protocol ID
- SRRSH2025-2020
- Other IDs
- ChiCTR2600115972
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Profile of Becotatug Vedotin(EGFR-Targeting ADC) in Combination With Pucotenlimab and Cisplatin as Neoadjuvant Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
- ClinicalTrials.gov ID
- NCT07393477
- Acronym / sponsor ID
- SRRSH2025-2020
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 6 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.
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
The primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy.
Main Questions This Trial Aims to Answer:
- Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)?
- What are the safety and tolerability profiles of the combination therapy?
- Does the treatment improve disease-free survival at 1 year after treatment?
What Participants Will Do:
Treatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting.
Treatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen.
Follow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy.
Outcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin | Experimental | Combination Product: Combination Therapy with Becotatug Vedotin, Pucotenlimab, and CisplatinParticipants in this arm will receive a combination of Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab (PD-1 Inhibitor), and Cisplatin as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The treatment will be administered for approximately 6-12 weeks, followed by surgery. Participants will be monitored for safety and efficacy through routine check-ups and pathological assessments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18-70 years (inclusive).
- Histopathologically confirmed Stage III/IVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual).
- Measurable primary lesions per RECIST v1.1.
- Treatment-naive (no prior anti-tumor therapy for current disease).
- ECOG performance status 0-1.
Key exclusion criteria (18 listed)
- Cachexia or multiple organ failure.
- Active autoimmune disease of any type.
- Concomitant second primary malignancy (e.g., esophageal cancer).
- Severe active infection requiring systemic therapy.
- Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart/cerebrovascular disease, uncontrolled diabetes/hypertension, active peptic ulcer).
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 |
|---|---|---|
| Combination Therapy with Becotatug Vedotin, Pucotenlimab, and CisplatinNeoadjuvant therapy: Becotatug Vedotin 2.0mg/kg + Pucotenlimab 200mg + Cisplatin 75mg/m2, all administered via intravenous infusion on Day 1 (d1), with a 21-day treatment cycle for a total of 2-4 cycles (the exact number of cycles is determined by the investigator based on imaging findings, laryngoscopy results, etc.) | Combination product | Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin |
Primary outcome
Pathological Complete Response(pCR) Rate
Time frame: Within 7 weeks after the completion of neoadjuvant therapy
2 secondary outcomes
Major Pathological Response(MPR) Rate
Time frame: Within 7 weeks after the completion of neoadjuvant therapy
1-Year Disease-Free Survival
Time frame: 1 year after enrollment
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 6 Feb 2026.
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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 Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma HNSCC, run by Sir Run Run Shaw 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 15 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: opening soon, as of the sponsor's last update on 6 Feb 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 Mang Xiao (+86 138 5714 3896, joelxm@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response(pCR) Rate (time frame: Within 7 weeks after the completion of neoadjuvant therapy). 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 6 Feb 2026.