Squamous Cell Carcinoma of Head and Neck (SCCHN)Phase 2NCT07915258
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
A Phase 2 study testing Becotatug Vedotin (MRG003) and Pucotenlimab in people with Squamous Cell Carcinoma of Head and Neck (SCCHN), run by Sun Yat-sen University at 4 sites in China.
Trial summary
Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) may receive chemotherapy combined with immunotherapy before surgery to reduce tumor size. However, some patients do not respond adequately to this initial treatment, and additional treatment options are needed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck (SCCHN)
- What is being tested?
- Becotatug Vedotin (MRG003) and Pucotenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2027to Dec 2030
- 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
- Voluntarily provides written informed consent before undergoing any study-specific procedures.
- Aged 18 to 70 years, regardless of sex.
- Histologically confirmed locally advanced (stage III-IVA, AJCC 8th edition) head and neck squamous cell carcinoma (HNSCC).
- Has received at least two cycles of induction immunochemotherapy comprising platinum-based chemotherapy and a PD-1 inhibitor.
- Has achieved stable disease (SD) or progressive disease (PD) as the best response to induction immunochemotherapy according to RECIST v1.1. A multidisciplinary team (MDT) considers that additional adaptive neoadjuvant therapy may reduce tumor burden, decrease the extent of surgical resection, or improve the opportunity for organ preservation.
- The interval between completion of induction immunochemotherapy and the first dose of study treatment does not exceed 28 days.
Show all 18Show fewer
- Disease remains amenable to curative-intent surgery with an anticipated R0 resection, as confirmed by an MDT including an experienced head and neck surgeon.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable lesion according to RECIST v1.1 before initiation of study treatment.
- Adequate organ function, as assessed within 7 days before the first study dose:
- Absolute neutrophil count ≥1.5 × 10⁹/L.
- Platelet count ≥100 × 10⁹/L.
- Hemoglobin ≥90 g/L.
- Total bilirubin ≤1.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN in the presence of liver metastases).
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- Women of childbearing potential and men whose partners are women of childbearing potential agree to use effective contraception throughout the study and for at least 6 months after the last dose.
- Willing and able to comply with study treatment, follow-up visits, laboratory examinations, and other protocol-required procedures.
Who cannot join
- Primary nasopharyngeal carcinoma.
- History of severe hypersensitivity to becotatug vedotin, pucotenlimab, or any of their excipients.
- Previous anticancer treatment for HNSCC other than the protocol-specified induction immunochemotherapy, including surgery, radiotherapy, other chemotherapy, targeted therapy, or biological therapy.
- Unresectable disease due to invasion of critical anatomical structures (e.g., carotid sheath involvement) or other factors, or medical contraindications to curative-intent surgery, as determined by the MDT.
- Distant metastatic disease (M1).
- Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment within the previous 2 years, except for permitted conditions such as vitiligo or stable hypothyroidism.
Show all 14Show fewer
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Requirement for long-term immunosuppressive therapy or use of systemic corticosteroids at immunosuppressive doses (>10 mg/day prednisone or equivalent) within 7 days before the first study dose.
- Human immunodeficiency virus (HIV) infection; untreated active hepatitis B infection (HBsAg-positive with HBV DNA >1,000 IU/mL); or hepatitis C infection (HCV antibody-positive with detectable HCV RNA).
- Pregnancy or breastfeeding.
- Severe or uncontrolled systemic disease, including clinically significant cardiovascular, pulmonary, infectious, or endocrine disorders.
- Major surgery or severe trauma within 4 weeks before the first study dose.
- Severe bleeding tendency or coagulation disorder, or clinically significant active bleeding within 1 month before the first study dose.
- Any other condition that, in the investigator's opinion, may compromise participant safety, study compliance, or interpretation of study results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, 510055
Yujie Liang, PhD, +86 13242879610, liangyj35@mail.sysu.edu.cn
Yujie Liang, PhD
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Puyun Ouyang, PhD, +86 20 87343571, ouyangpy@sysucc.org.cn
Puyun Ouyang, PhD
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zhanhong Chen, PhD, +86 20 85253333, chenanonz@163.com
Zhanhong Chen, PhD
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong
Jun Li, PhD, +86 755 28932833
Jun Li, PhD
About this study
Official title: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study of Becotatug Vedotin Combined With Pucotenlimab in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) may receive chemotherapy combined with immunotherapy before surgery to reduce tumor size. However, some patients do not respond adequately to this initial treatment, and additional treatment options are needed.
This study aims to evaluate the effectiveness and safety of combining becotatug vedotin (MRG003), an antibody-drug conjugate that targets the epidermal growth factor receptor (EGFR), with pucotenlimab (HX008), a PD-1 immune checkpoint inhibitor, in patients whose disease remains stable or progresses after induction immunotherapy combined with platinum-based chemotherapy.
Read more
This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible patients with locally advanced, resectable HNSCC will receive two cycles of becotatug vedotin plus pucotenlimab, administered every three weeks before surgery. After treatment, patients will undergo tumor response assessment followed by curative-intent surgery and appropriate postoperative treatment.
The primary objective is to evaluate the objective response rate (ORR), defined as the proportion of patients achieving complete or partial tumor response. The study will also assess pathological response, surgical outcomes, treatment safety, and long-term survival.
The study seeks to determine whether this additional preoperative treatment strategy may improve tumor response and provide further opportunities for organ preservation in patients who have not benefited adequately from initial induction immunochemotherapy.
Read the detailed description
Background and Rationale
Locally advanced head and neck squamous cell carcinoma (HNSCC) often requires extensive surgical resection, which may significantly impair speech, swallowing, appearance, and quality of life. Although induction immunochemotherapy combining platinum-based chemotherapy with programmed cell death protein 1 (PD-1) inhibitors has demonstrated promising antitumor activity, a proportion of patients experience stable disease (SD) or progressive disease (PD). These patients may have limited opportunities for tumor downstaging and organ preservation before definitive surgery.
Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) that delivers a cytotoxic payload to tumor cells. Pucotenlimab (HX008) is a PD-1 inhibitor that enhances antitumor immune responses. The combination may provide complementary antitumor mechanisms and represents a potential treatment strategy for patients with inadequate responses to previous induction immunochemotherapy.
Study Design and Treatment
This is a prospective, multicenter, open-label, single-arm, phase II clinical study designed to evaluate the efficacy and safety of becotatug vedotin combined with pucotenlimab as an adaptive neoadjuvant treatment strategy.
Eligible participants will have histologically confirmed, locally advanced (stage III-IVA), resectable HNSCC with SD or PD following at least two cycles of induction immunochemotherapy containing platinum-based chemotherapy and a PD-1 inhibitor, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Resectability will be confirmed by a multidisciplinary team.
Participants will receive becotatug vedotin at 2.0 mg/kg intravenously and pucotenlimab at 200 mg intravenously, administered every three weeks for two cycles.
Following completion of study treatment, radiological tumor response will be assessed before curative-intent surgery. Postoperative adjuvant treatment, including radiotherapy with or without chemotherapy, will be administered according to standard clinical practice.
Study Objectives and Assessments
The primary objective is to evaluate the objective response rate (ORR) according to RECIST v1.1 after adaptive neoadjuvant therapy.
Secondary assessments include pathological complete response, major pathological response, R0 resection, organ preservation, safety, perioperative complications, and survival outcomes, including event-free survival, disease-free survival, and overall survival.
Exploratory analyses of tumor tissue and peripheral blood samples will investigate potential biomarkers associated with treatment response and mechanisms underlying resistance to induction immunochemotherapy.
Statistical Design
A Simon's two-stage minimax design will be employed, with a null ORR of 10%, a target ORR of 35%, a one-sided significance level of 0.05, and 80% statistical power.
In the first stage, 11 evaluable participants will be enrolled. If no more than one participant achieves a complete or partial response, the study will be stopped early for insufficient efficacy. If at least two participants achieve an objective response, an additional seven evaluable participants will be enrolled, resulting in a total of 18 evaluable participants.
If at least five of the 18 evaluable participants achieve an objective response, the regimen will be considered to have sufficient antitumor activity to warrant further investigation.
Allowing for approximately 15% attrition or non-evaluable participants, up to 22 participants are planned to be enrolled.
Safety and Follow-up
Adverse events, serious adverse events, immune-related adverse events, and perioperative complications will be monitored throughout the study. Participants will undergo postoperative follow-up, including imaging assessments for disease recurrence and long-term survival evaluation, according to the study protocol.
- Being tested
- Becotatug Vedotin (MRG003), Pucotenlimab
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Adaptive neoadjuvant therapy, Induction immunochemotherapy, Antibody-drug conjugate, Becotatug vedotin (MRG003), Pucotenlimab (HX008)
- 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 (MRG003)Drug
Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC). It will be administered intravenously at a dose of 2.0 mg/kg on Day 1 of each 21-day cycle for two cycles, in combination with pucotenlimab.
PucotenlimabDrug
Pucotenlimab (HX008) is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). It will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle for two cycles, in combination with becotatug vedotin.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Neoadjuvant Therapy | Experimental | Patients with locally advanced, resectable head and neck squamous cell carcinoma who have achieved stable disease or progressive disease following induction immunochemotherapy will receive becotatug vedotin (MRG003) at 2.0 mg/kg and pucotenlimab (HX008) at 200 mg intravenously every three weeks for two cycles, followed by curative-intent surgery and standard postoperative treatment as clinically indicated. Receives: Drug: Becotatug Vedotin (MRG003); Drug: Pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants achieving a complete response (CR) or partial response (PR), as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), based on radiological assessments before and after adaptive neoadjuvant treatment. The ORR will be reported with an exact 95% confidence interval using the Clopper-Pearson method.
Measured: From baseline to preoperative tumor assessment after two treatment cycles (approximately 6-10 weeks after the first dose)
Secondary outcomes (9)
Pathological Complete Response Rate (pCR)
The proportion of participants with no residual viable invasive tumor cells in the primary tumor bed and all regional lymph nodes, as determined by histopathological examination of surgical specimens.
Measured: At curative-intent surgery, approximately 6-12 weeks after the first study dose
Major Pathological Response Rate (MPR)
The proportion of participants with 10% or less residual viable tumor cells in the resected tumor tissue, as assessed by histopathological examination.
Measured: At curative-intent surgery, approximately 6-12 weeks after the first study dose
R0 Resection Rate
The proportion of participants undergoing curative-intent surgery who achieve microscopically negative surgical margins (R0 resection), as confirmed by histopathological examination.
Measured: At curative-intent surgery, approximately 6-12 weeks after the first study dose
Organ Preservation Rate
Among participants assessed by a multidisciplinary team before study enrollment as requiring function-ablative surgery, the proportion who undergo organ-function-preserving surgery while achieving R0 resection after adaptive neoadjuvant treatment.
Measured: From baseline surgical assessment to definitive surgery, approximately 6-12 weeks after the first study dose
Incidence of Adverse Events (AEs)
The incidence and severity of adverse events, serious adverse events, and immune-related adverse events, graded according to NCI CTCAE version 6.0. Treatment-related events, events leading to dose modification or discontinuation, and perioperative complications will also be assessed.
Measured: From first study drug administration through the protocol-defined safety follow-up period (up to 48 months)
Event-Free Survival (EFS) Rate at 1 and 2 Years
The estimated proportion of participants remaining event-free at 1 year and 2 years after initiation of adaptive neoadjuvant therapy, calculated using the Kaplan-Meier method according to the protocol-defined event criteria.
Measured: At 1 year and 2 years after the first study dose
Disease-Free Survival (DFS) Rate at 1 and 2 Years
The estimated proportion of participants remaining disease-free at 1 year and 2 years following curative-intent surgery, calculated using the Kaplan-Meier method.
Measured: At 1 year and 2 years after curative-intent surgery
Overall Survival (OS) Rate at 1 and 2 Years
The estimated proportion of participants alive at 1 year and 2 years after initiation of adaptive neoadjuvant therapy, calculated using the Kaplan-Meier method.
Measured: At 1 year and 2 years after the first study dose
Clinicopathological Downstaging Rate
The proportion of participants whose postoperative pathological TNM stage (pTNM) is lower than the clinical TNM stage (cTNM) assessed after induction immunochemotherapy and before adaptive neoadjuvant treatment.
Measured: From baseline staging to postoperative pathological assessment, approximately 6-12 weeks after the first study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and Neck (SCCHN)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, open-label, single-arm, phase II clinical trial using a Simon's two-stage minimax design. All eligible participants will receive two cycles of becotatug vedotin combined with pucotenlimab as adaptive neoadjuvant therapy following an inadequate response to induction immunochemotherapy, followed by planned curative-intent surgery. The study includes an interim efficacy analysis with a predefined early stopping rule for insufficient antitumor activity.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Lepu Biopharma Co., Ltd.
- Responsible party
- Principal investigator, Yujie Liang, Hospital of Stomatology, Sun Yat-Sen University
- Investigators
- Yujie Liang, PhD, Principal investigator, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915258
- Sponsor's protocol ID
- GHKQ-202608-L001
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share de-identified individual participant data (IPD) with researchers outside the study team. Study data will be managed in accordance with the approved protocol, informed consent, institutional ethics requirements, and applicable Chinese regulations. Aggregate study findings may be disseminated through scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Phase II Clinical Study of Becotatug Vedotin Combined With Pucotenlimab in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
- ClinicalTrials.gov ID
- NCT07915258
- Acronym / sponsor ID
- GHKQ-202608-L001
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Adaptive neoadjuvant therapy, Induction immunochemotherapy, Antibody-drug conjugate, Becotatug vedotin (MRG003), Pucotenlimab (HX008)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Lepu Biopharma Co., Ltd.
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Nov 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.
Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) may receive chemotherapy combined with immunotherapy before surgery to reduce tumor size. However, some patients do not respond adequately to this initial treatment, and additional treatment options are needed.
This study aims to evaluate the effectiveness and safety of combining becotatug vedotin (MRG003), an antibody-drug conjugate that targets the epidermal growth factor receptor (EGFR), with pucotenlimab (HX008), a PD-1 immune checkpoint inhibitor, in patients whose disease remains stable or progresses after induction immunotherapy combined with platinum-based chemotherapy.
This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible patients with locally advanced, resectable HNSCC will receive two cycles of becotatug vedotin plus pucotenlimab, administered every three weeks before surgery. After treatment, patients will undergo tumor response assessment followed by curative-intent surgery and appropriate postoperative treatment.
The primary objective is to evaluate the objective response rate (ORR), defined as the proportion of patients achieving complete or partial tumor response. The study will also assess pathological response, surgical outcomes, treatment safety, and long-term survival.
The study seeks to determine whether this additional preoperative treatment strategy may improve tumor response and provide further opportunities for organ preservation in patients who have not benefited adequately from initial induction immunochemotherapy.
Detailed description
Background and Rationale
Locally advanced head and neck squamous cell carcinoma (HNSCC) often requires extensive surgical resection, which may significantly impair speech, swallowing, appearance, and quality of life. Although induction immunochemotherapy combining platinum-based chemotherapy with programmed cell death protein 1 (PD-1) inhibitors has demonstrated promising antitumor activity, a proportion of patients experience stable disease (SD) or progressive disease (PD). These patients may have limited opportunities for tumor downstaging and organ preservation before definitive surgery.
Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) that delivers a cytotoxic payload to tumor cells. Pucotenlimab (HX008) is a PD-1 inhibitor that enhances antitumor immune responses. The combination may provide complementary antitumor mechanisms and represents a potential treatment strategy for patients with inadequate responses to previous induction immunochemotherapy.
Study Design and Treatment
This is a prospective, multicenter, open-label, single-arm, phase II clinical study designed to evaluate the efficacy and safety of becotatug vedotin combined with pucotenlimab as an adaptive neoadjuvant treatment strategy.
Eligible participants will have histologically confirmed, locally advanced (stage III-IVA), resectable HNSCC with SD or PD following at least two cycles of induction immunochemotherapy containing platinum-based chemotherapy and a PD-1 inhibitor, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Resectability will be confirmed by a multidisciplinary team.
Participants will receive becotatug vedotin at 2.0 mg/kg intravenously and pucotenlimab at 200 mg intravenously, administered every three weeks for two cycles.
Following completion of study treatment, radiological tumor response will be assessed before curative-intent surgery. Postoperative adjuvant treatment, including radiotherapy with or without chemotherapy, will be administered according to standard clinical practice.
Study Objectives and Assessments
The primary objective is to evaluate the objective response rate (ORR) according to RECIST v1.1 after adaptive neoadjuvant therapy.
Secondary assessments include pathological complete response, major pathological response, R0 resection, organ preservation, safety, perioperative complications, and survival outcomes, including event-free survival, disease-free survival, and overall survival.
Exploratory analyses of tumor tissue and peripheral blood samples will investigate potential biomarkers associated with treatment response and mechanisms underlying resistance to induction immunochemotherapy.
Statistical Design
A Simon's two-stage minimax design will be employed, with a null ORR of 10%, a target ORR of 35%, a one-sided significance level of 0.05, and 80% statistical power.
In the first stage, 11 evaluable participants will be enrolled. If no more than one participant achieves a complete or partial response, the study will be stopped early for insufficient efficacy. If at least two participants achieve an objective response, an additional seven evaluable participants will be enrolled, resulting in a total of 18 evaluable participants.
If at least five of the 18 evaluable participants achieve an objective response, the regimen will be considered to have sufficient antitumor activity to warrant further investigation.
Allowing for approximately 15% attrition or non-evaluable participants, up to 22 participants are planned to be enrolled.
Safety and Follow-up
Adverse events, serious adverse events, immune-related adverse events, and perioperative complications will be monitored throughout the study. Participants will undergo postoperative follow-up, including imaging assessments for disease recurrence and long-term survival evaluation, according to the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, open-label, single-arm, phase II clinical trial using a Simon's two-stage minimax design. All eligible participants will receive two cycles of becotatug vedotin combined with pucotenlimab as adaptive neoadjuvant therapy following an inadequate response to induction immunochemotherapy, followed by planned curative-intent surgery. The study includes an interim efficacy analysis with a predefined early stopping rule for insufficient antitumor activity.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Neoadjuvant Therapy | Experimental | Drug: Becotatug Vedotin (MRG003), Drug: PucotenlimabPatients with locally advanced, resectable head and neck squamous cell carcinoma who have achieved stable disease or progressive disease following induction immunochemotherapy will receive becotatug vedotin (MRG003) at 2.0 mg/kg and pucotenlimab (HX008) at 200 mg intravenously every three weeks for two cycles, followed by curative-intent surgery and standard postoperative treatment as clinically indicated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily provides written informed consent before undergoing any study-specific procedures.
- Aged 18 to 70 years, regardless of sex.
- Histologically confirmed locally advanced (stage III-IVA, AJCC 8th edition) head and neck squamous cell carcinoma (HNSCC).
- Has received at least two cycles of induction immunochemotherapy comprising platinum-based chemotherapy and a PD-1 inhibitor.
- Has achieved stable disease (SD) or progressive disease (PD) as the best response to induction immunochemotherapy according to RECIST v1.1. A multidisciplinary team (MDT) considers that additional adaptive neoadjuvant therapy may reduce tumor burden, decrease the extent of surgical resection, or improve the opportunity for organ preservation.
Key exclusion criteria (14 listed)
- Primary nasopharyngeal carcinoma.
- History of severe hypersensitivity to becotatug vedotin, pucotenlimab, or any of their excipients.
- Previous anticancer treatment for HNSCC other than the protocol-specified induction immunochemotherapy, including surgery, radiotherapy, other chemotherapy, targeted therapy, or biological therapy.
- Unresectable disease due to invasion of critical anatomical structures (e.g., carotid sheath involvement) or other factors, or medical contraindications to curative-intent surgery, as determined by the MDT.
- Distant metastatic disease (M1).
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 (MRG003)Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC). It will be administered intravenously at a dose of 2.0 mg/kg on Day 1 of each 21-day cycle for two cycles, in combination with pucotenlimab. | Drug | Adaptive Neoadjuvant Therapy |
| PucotenlimabPucotenlimab (HX008) is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). It will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle for two cycles, in combination with becotatug vedotin. | Drug | Adaptive Neoadjuvant Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: From baseline to preoperative tumor assessment after two treatment cycles (approximately 6-10 weeks after the first dose)
The proportion of participants achieving a complete response (CR) or partial response (PR), as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), based on radiological assessments before and after adaptive neoadjuvant treatment. The ORR will be reported with an exact 95% confidence interval using the Clopper-Pearson method.
9 secondary outcomes
Pathological Complete Response Rate (pCR)
Time frame: At curative-intent surgery, approximately 6-12 weeks after the first study dose
Major Pathological Response Rate (MPR)
Time frame: At curative-intent surgery, approximately 6-12 weeks after the first study dose
R0 Resection Rate
Time frame: At curative-intent surgery, approximately 6-12 weeks after the first study dose
Organ Preservation Rate
Time frame: From baseline surgical assessment to definitive surgery, approximately 6-12 weeks after the first study dose
Incidence of Adverse Events (AEs)
Time frame: From first study drug administration through the protocol-defined safety follow-up period (up to 48 months)
Event-Free Survival (EFS) Rate at 1 and 2 Years
Time frame: At 1 year and 2 years after the first study dose
Disease-Free Survival (DFS) Rate at 1 and 2 Years
Time frame: At 1 year and 2 years after curative-intent surgery
Overall Survival (OS) Rate at 1 and 2 Years
Time frame: At 1 year and 2 years after the first study dose
Clinicopathological Downstaging Rate
Time frame: From baseline staging to postoperative pathological assessment, approximately 6-12 weeks after the first study dose
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 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share de-identified individual participant data (IPD) with researchers outside the study team. Study data will be managed in accordance with the approved protocol, informed consent, institutional ethics requirements, and applicable Chinese regulations. Aggregate study findings may be disseminated through scientific publications.
Related trials for Squamous Cell Carcinoma of Head and Neck (SCCHN)
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 2
Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
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.
Yujie Liang, PhD principal investigator
Hospital of Stomatology, Sun Yat-Sen University
4 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 (MRG003) and Pucotenlimab in people with Squamous Cell Carcinoma of Head and Neck (SCCHN), run by Sun Yat-sen University at 4 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 18 inclusion and 14 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 Yujie Liang, PhD (+86 13242879610, liangyj35@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From baseline to preoperative tumor assessment after two treatment cycles (approximately 6-10 weeks after the first dose)). 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 4 Nov 2026.