LA HNSCCPhase 2NCT07707167
A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Pucotenlimab, Becotatug vedotin and Radiotherapy in people with LA HNSCC, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- LA HNSCC
- What is being tested?
- Pucotenlimab, Becotatug vedotin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of any malignancy other than gastric cancer within 5 years prior to the first dose, with the exception of adequately treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
- Known endoscopic evidence of active bleeding in the target lesion;
- Concurrent participation in another interventional clinical study, or receipt of any investigational medicinal product or use of investigational device within 4 weeks prior to the first dose;
- Prior exposure to any of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents; agents targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, and CD137); or antibody-drug conjugates (ADCs) with MMAE or MMAF payloads;
- Systemic administration of Chinese proprietary medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, and interleukins, except for local administration to control pleural effusion) within 2 weeks prior to the first dose;
- Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy;
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- Receipt of systemic corticosteroid therapy (excluding intranasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose; *Note: Physiologic doses of corticosteroids (prednisone ≤10 mg/day or equivalent) are permitted;*
- History of allogeneic organ transplantation (corneal transplantation excluded) or allogeneic hematopoietic stem cell transplantation;
- Known hypersensitivity to pucotenlimab, MRG003, or any of their excipients;
- Failure to recover adequately from toxicities and/or complications of prior interventions (i.e., to Grade ≤1 or to baseline, excluding fatigue and alopecia) prior to initiation of study treatment;
- Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive);
- Untreated active hepatitis B infection (defined as HBsAg positivity with HBV-DNA copy number above the upper limit of normal of the local laboratory); *Note: Subjects with hepatitis B may be enrolled if they meet the following criteria:* 1) HBV viral load <1,000 copies/mL (200 IU/mL) prior to the first dose; subjects must receive prophylactic anti-HBV therapy throughout the study treatment period to prevent viral reactivation; 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load are not required to receive prophylactic anti-HBV therapy but require close monitoring for viral reactivation;
- Active hepatitis C infection (HCV antibody positive with HCV-RNA level above the lower limit of quantification);
- Receipt of a live vaccine within 30 days prior to Cycle 1 Day 1; *Note: Inactivated injectable influenza vaccines for seasonal influenza are permitted within 30 days prior to the first dose; intranasal live-attenuated influenza vaccines are not permitted;*
- Pregnancy or breastfeeding;
- Presence of any serious or uncontrolled systemic condition, including but not limited to:
- 1) Resting ECG demonstrating significant, symptomatic, and poorly controlled abnormalities in rhythm, conduction, or morphology, including complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) Class ≥2; 3) Any arterial thrombosis, embolism, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to enrollment; 4) Inadequately controlled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); 5) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) Active or uncontrolled infection requiring systemic antimicrobial therapy; 8) Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; 9) Hepatic conditions including cirrhosis, decompensated liver disease, or acute or chronic active hepatitis; 10) Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L); 11) Urinalysis demonstrating urine protein ≥2+ with confirmed 24-hour urine protein >1.0 g; 12) Psychiatric disorder that would preclude compliance with study requirements;
- 17. Any medical condition, laboratory abnormality, or concurrent therapy that, in the Investigator's opinion, may interfere with study assessments, compromise subject safety, or render the subject unsuitable for study participation.
Who cannot join
- Presence of distant metastatic lesions;
- History of Grade ≥3 immune-related adverse events or treatment-related adverse events that have not recovered to Grade ≤1;
- Receipt of surgery, chemotherapy, targeted small molecule therapy, or radiotherapy for another invasive malignancy within the past 5 years;
- Autoimmune disease requiring systemic corticosteroid therapy within the past 3 months, history of clinically significant autoimmune disease, or syndrome requiring systemic corticosteroid therapy;
- Active infection requiring systemic treatment;
- Prior receipt of any form of anti-tumor therapy for the primary tumor or metastatic lymph nodes, including chemotherapy, radiotherapy, targeted therapy, anti-PD-1 or anti-PD-L1 therapy, or surgery (biopsy excluded);
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- History of other malignancies;
- History of organ transplantation;
- History of autoimmune disease, or other conditions requiring long-term systemic corticosteroid or immunosuppressive therapy;
- Positive for human immunodeficiency virus (HIV);
- Active hepatitis B or hepatitis C infection (HBV DNA or HCV RNA above the upper limit of normal);
- Total white blood cell count <3.5×10⁹/L, absolute lymphocyte count <0.8×10⁹/L, neutrophil count <1.5×10⁹/L, platelet count <100×10⁹/L, or hemoglobin <90 g/L; total bilirubin >1.5× upper limit of normal (ULN), transaminases (AST, ALT) >3× ULN (>5× ULN if hepatic metastases present), serum creatinine >1.5× ULN; coagulation abnormalities with international normalized ratio (INR) or prothrombin time (PT) >1.5× ULN;
- Serious cardiovascular, respiratory, or major immune system comorbidities; including urinary tract obstruction, myocardial infarction, arrhythmia, obstructive or restrictive lung disease, or other conditions that the Investigator considers may increase subject risk;
- Pregnant or lactating women;
- Refusal to use effective contraception during the treatment period and for 3 months thereafter;
- Concurrent participation in another clinical study;
- Critically ill patients unable to complete the study assessments;
- History of psychiatric disorders (e.g., schizophrenia, mania, anxiety disorder, depression, phobia, etc.) or subjects/spouses diagnosed with psychiatric illness at the time of study enrollment;
- Subjects or spouses with communication barriers or inability to provide normal responses due to altered consciousness, aphasia, intellectual disability, or other causes;
- Any other condition that the Investigator considers renders the subject unsuitable for enrollment or may interfere with subject 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.
About this study
Official title: A Prospective, Exploratory Clinical Study of Becotatug Vedotin Combined With Putlimab as Neoadjuvant Therapy Prior to Surgery and Adjuvant Radiotherapy After Surgery in Locally Advanced Head and Neck Squamous Cell Carcinoma
This is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC).
Neoadjuvant Phase (3-week cycle, 2 cycles):
Read more
- Putlimab (HX008): 200 mg, Q3W, D1, IV
- Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV
Adjuvant/Maintenance Phase: Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion.
Group A (Postoperative pCR):
- Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
- Adjuvant RT: 40 Gy/5 weeks
Group B (Postoperative MPR):
- Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
- Adjuvant RT: 50 Gy/5 weeks
Group C (Postoperative Partial/No Response):
- Low-risk (no extracapsular nodal extension [ENE] and negative margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60 Gy/6 weeks
- High-risk (ENE and/or positive margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60-66 Gy/6-6.6 weeks + Cisplatin 60 mg/m², Q3W, D1, IV, for 2 cycles
RT timing, field, and fractionation may be adjusted by investigators based on individual disease status.
Imaging assessment every 2 cycles (±7 days) until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated.
Read the detailed description
Neoadjuvant Phase (3-week cycle, 2 cycles):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), for 2 cycles Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV infusion (60 ± 10 min, first cycle ≥ 60 min), administered at least 30 min after completion of putlimab infusion, for 2 cycles For subjects unable to tolerate 60-min infusion, the infusion time may be extended to 120 min. Efficacy assessment will be performed every cycle until completion of 2 cycles followed by surgical resection or occurrence of discontinuation events (clinical progression, investigator-confirmed radiographic progression per RECIST 1.1, unacceptable toxicity, withdrawal of informed consent, or meeting criteria for intervention discontinuation).
Adjuvant/Maintenance Phase (3-week cycle):
Surgical resection within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion. Postoperative pathological response (pCR and MPR) will be determined based on the percentage of residual visible tumor relative to total tumor bed area on H\&E-stained slides. Postoperative maintenance treatment will be administered in 3-week cycles. Adjuvant treatment will be selected based on pathological response: Group A (postoperative pCR); Group B (postoperative MPR); Group C (postoperative partial response/no response), further stratified into low/intermediate-risk (no extracapsular nodal extension [ENE] and negative margins) and high-risk (ENE and/or positive margins). All patients will receive putlimab (PD-1) maintenance therapy for a total duration of up to 1 year.
Post-discontinuation Standard Therapy:
Subjects unable to tolerate or unwilling to receive the study-specified adjuvant treatment after surgery will be withdrawn from the study and return to standard clinical chemoradiotherapy. Only neoadjuvant treatment data and postoperative assessment results will be retained for these patients.
Group A (Postoperative pCR):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 40 Gy/5 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
Group B (Postoperative MPR):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 50 Gy/5 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
Group C (Postoperative Partial Response/No Response):
Low/Intermediate-Risk (no ENE and negative margins):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 60 Gy/6 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
High-Risk (ENE and/or positive margins):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 60-66 Gy/6-6.6 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status Cisplatin: 60 mg/m², Q3W, D1, IV infusion, administered at least 30 min after completion of putlimab infusion, for 2 cycles
Imaging Assessment:
Imaging assessments will be performed every 2 cycles (±7 days) from treatment initiation until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated. Subjects must complete safety assessments and imaging evaluation at the end of treatment, followed by a safety follow-up visit 30 days after the last dose. Survival follow-up will then be conducted every 90 days (±7 days) to collect and record survival status and subsequent anti-tumor therapy.
Endpoints:
The primary endpoint is the postoperative pathological complete response (pCR) rate. Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), median event-free survival (mEFS), median overall survival (mOS), 1-year/2-year EFS/OS rates, and adverse event rates per NCI-CTCAE v6.0.
Study Size and Duration:
The study plans to enroll 35 subjects and is expected to be completed within 3 years.
- Conditions
- LA HNSCC
- Being tested
- Pucotenlimab, Becotatug vedotin, Radiotherapy
- Keywords
- Becotatug vedotin, Pucotenlimab, Sequential radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PucotenlimabDrug
Neoadjuvant Phase: All subjects will receive 2 cycles of Putlimab (HX008): 200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min). Adjuvant Phase: All subjects will receive Putlimab for up to 1 year，200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min).
Becotatug vedotinDrug
Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV(60 ± 15 min, first cycle infusion ≥ 60 min).
RadiotherapyRadiation
Adjuvant Phase: All subjects will receive varying degrees of chemoradiotherapy based on their pathological response and nodal involvement status. Group A (Postoperative pCR): RT 40 Gy/5 weeks. **Group B (Postoperative MPR): RT 50 Gy/5 weeks.；Group C (Postoperative Partial Response/No Response): (1) Low/Intermediate-risk subjects (no extracapsular nodal extension [ENE] and negative margins): RT 60 Gy/6 weeks; (2) High-risk subjects (ENE and/or positive margins): RT 60-66 Gy/6-6.6 weeks combined with cisplatin. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV; and Putlimab (HX008): 200 mg, Q3W, D1, IV. Adjuvant Phase: All subjects will receive Putlimab for up to 1 year, with varying degrees of chemoradiotherapy added based on each subject's pathological response and nodal involvement status. Receives: Drug: Pucotenlimab; Drug: Becotatug vedotin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response
Measured: Periprocedural
Secondary outcomes (6)
Major pathological response
Measured: Periprocedural
Objective Response Rate
Measured: At the end of Cycle 2 (each cycle is 21 days)
Disease Control Rate
Measured: At the end of Cycle 2 (each cycle is 21 days)
Event-Free Survival
Measured: 2 years after surgery
Overall survival
Measured: 2 years after surgery
Safety
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: At the end of every 2 treatment cycles (21-day cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LA HNSCCStudies 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
- Model description
- Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV; and Putlimab (HX008): 200 mg, Q3W, D1, IV. Adjuvant Phase: All subjects will receive Putlimab for up to 1 year, with varying degrees of chemoradiotherapy added based on each subject's pathological response and nodal involvement status.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lirong Wu, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707167
- Sponsor's protocol ID
- EGFR-ADC-LA-HNSCC
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 16 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Clinical Study of Becotatug Vedotin Combined With Putlimab as Neoadjuvant Therapy Prior to Surgery and Adjuvant Radiotherapy After Surgery in Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07707167
- Acronym / sponsor ID
- EGFR-ADC-LA-HNSCC
- Conditions
- LA HNSCC
- Keywords
- Becotatug vedotin, Pucotenlimab, Sequential radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 16 Jul 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 is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC).
Neoadjuvant Phase (3-week cycle, 2 cycles):
- Putlimab (HX008): 200 mg, Q3W, D1, IV
- Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV
Adjuvant/Maintenance Phase: Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion.
Group A (Postoperative pCR):
- Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
- Adjuvant RT: 40 Gy/5 weeks
Group B (Postoperative MPR):
- Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
- Adjuvant RT: 50 Gy/5 weeks
Group C (Postoperative Partial/No Response):
- Low-risk (no extracapsular nodal extension [ENE] and negative margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60 Gy/6 weeks
- High-risk (ENE and/or positive margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60-66 Gy/6-6.6 weeks + Cisplatin 60 mg/m², Q3W, D1, IV, for 2 cycles
RT timing, field, and fractionation may be adjusted by investigators based on individual disease status.
Imaging assessment every 2 cycles (±7 days) until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated.
Detailed description
Neoadjuvant Phase (3-week cycle, 2 cycles):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), for 2 cycles Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV infusion (60 ± 10 min, first cycle ≥ 60 min), administered at least 30 min after completion of putlimab infusion, for 2 cycles For subjects unable to tolerate 60-min infusion, the infusion time may be extended to 120 min. Efficacy assessment will be performed every cycle until completion of 2 cycles followed by surgical resection or occurrence of discontinuation events (clinical progression, investigator-confirmed radiographic progression per RECIST 1.1, unacceptable toxicity, withdrawal of informed consent, or meeting criteria for intervention discontinuation).
Adjuvant/Maintenance Phase (3-week cycle):
Surgical resection within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion. Postoperative pathological response (pCR and MPR) will be determined based on the percentage of residual visible tumor relative to total tumor bed area on H\&E-stained slides. Postoperative maintenance treatment will be administered in 3-week cycles. Adjuvant treatment will be selected based on pathological response: Group A (postoperative pCR); Group B (postoperative MPR); Group C (postoperative partial response/no response), further stratified into low/intermediate-risk (no extracapsular nodal extension [ENE] and negative margins) and high-risk (ENE and/or positive margins). All patients will receive putlimab (PD-1) maintenance therapy for a total duration of up to 1 year.
Post-discontinuation Standard Therapy:
Subjects unable to tolerate or unwilling to receive the study-specified adjuvant treatment after surgery will be withdrawn from the study and return to standard clinical chemoradiotherapy. Only neoadjuvant treatment data and postoperative assessment results will be retained for these patients.
Group A (Postoperative pCR):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 40 Gy/5 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
Group B (Postoperative MPR):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 50 Gy/5 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
Group C (Postoperative Partial Response/No Response):
Low/Intermediate-Risk (no ENE and negative margins):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 60 Gy/6 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status
High-Risk (ENE and/or positive margins):
Putlimab (HX008): 200 mg, Q3W, D1, IV infusion (60 ± 15 min, first cycle ≥ 60 min), up to 1 year Adjuvant RT: 60-66 Gy/6-6.6 weeks. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status Cisplatin: 60 mg/m², Q3W, D1, IV infusion, administered at least 30 min after completion of putlimab infusion, for 2 cycles
Imaging Assessment:
Imaging assessments will be performed every 2 cycles (±7 days) from treatment initiation until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated. Subjects must complete safety assessments and imaging evaluation at the end of treatment, followed by a safety follow-up visit 30 days after the last dose. Survival follow-up will then be conducted every 90 days (±7 days) to collect and record survival status and subsequent anti-tumor therapy.
Endpoints:
The primary endpoint is the postoperative pathological complete response (pCR) rate. Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), median event-free survival (mEFS), median overall survival (mOS), 1-year/2-year EFS/OS rates, and adverse event rates per NCI-CTCAE v6.0.
Study Size and Duration:
The study plans to enroll 35 subjects and is expected to be completed within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV; and Putlimab (HX008): 200 mg, Q3W, D1, IV. Adjuvant Phase: All subjects will receive Putlimab for up to 1 year, with varying degrees of chemoradiotherapy added based on each subject's pathological response and nodal involvement status.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Pucotenlimab, Drug: Becotatug vedotin, Radiation: RadiotherapyNeoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV; and Putlimab (HX008): 200 mg, Q3W, D1, IV. Adjuvant Phase: All subjects will receive Putlimab for up to 1 year, with varying degrees of chemoradiotherapy added based on each subject's pathological response and nodal involvement status. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of any malignancy other than gastric cancer within 5 years prior to the first dose, with the exception of adequately treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
- Known endoscopic evidence of active bleeding in the target lesion;
- Concurrent participation in another interventional clinical study, or receipt of any investigational medicinal product or use of investigational device within 4 weeks prior to the first dose;
- Prior exposure to any of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents; agents targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, and CD137); or antibody-drug conjugates (ADCs) with MMAE or MMAF payloads;
- Systemic administration of Chinese proprietary medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, and interleukins, except for local administration to control pleural effusion) within 2 weeks prior to the first dose;
Key exclusion criteria (20 listed)
- Presence of distant metastatic lesions;
- History of Grade ≥3 immune-related adverse events or treatment-related adverse events that have not recovered to Grade ≤1;
- Receipt of surgery, chemotherapy, targeted small molecule therapy, or radiotherapy for another invasive malignancy within the past 5 years;
- Autoimmune disease requiring systemic corticosteroid therapy within the past 3 months, history of clinically significant autoimmune disease, or syndrome requiring systemic corticosteroid therapy;
- Active infection requiring systemic 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 |
|---|---|---|
| PucotenlimabNeoadjuvant Phase: All subjects will receive 2 cycles of Putlimab (HX008): 200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min). Adjuvant Phase: All subjects will receive Putlimab for up to 1 year，200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min). | Drug | Experimental |
| Becotatug vedotinNeoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV(60 ± 15 min, first cycle infusion ≥ 60 min). | Drug | Experimental |
| RadiotherapyAdjuvant Phase: All subjects will receive varying degrees of chemoradiotherapy based on their pathological response and nodal involvement status. Group A (Postoperative pCR): RT 40 Gy/5 weeks. **Group B (Postoperative MPR): RT 50 Gy/5 weeks.；Group C (Postoperative Partial Response/No Response): (1) Low/Intermediate-risk subjects (no extracapsular nodal extension [ENE] and negative margins): RT 60 Gy/6 weeks; (2) High-risk subjects (ENE and/or positive margins): RT 60-66 Gy/6-6.6 weeks combined with cisplatin. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status. | Radiation | Experimental |
Primary outcome
Pathologic response
Time frame: Periprocedural
6 secondary outcomes
Major pathological response
Time frame: Periprocedural
Objective Response Rate
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Disease Control Rate
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Event-Free Survival
Time frame: 2 years after surgery
Overall survival
Time frame: 2 years after surgery
Safety
Time frame: At the end of every 2 treatment cycles (21-day cycle)
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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HNSCC
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JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Carcinoma, Squamous Cell
Not yet recruitingPhase 2
Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC
HPV-unrelated Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 3
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Head and Neck Neoplasms
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 Pucotenlimab, Becotatug vedotin and Radiotherapy in people with LA HNSCC, run by Jiangsu Cancer Institute & 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 18 inclusion and 20 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 16 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 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 WuLi MD Rong (+86-13701588737, wulirong126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response (time frame: Periprocedural). 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 16 Jul 2026.