A Phase 2 interventional study of Pucotenlimab and Becotatug vedotin in LA HNSCC, sponsored by Jiangsu Cancer Institute & Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Jiangsu Cancer Institute & Hospital · Phase 2, Interventional, and Treatment
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):
**Adjuvant/Maintenance Phase:** Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion.
**Group A (Postoperative pCR):**
**Group B (Postoperative MPR):**
**Group C (Postoperative Partial/No Response):**
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.
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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 35 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Jiangsu Cancer Institute & Hospital is the lead sponsor of 40 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Resting 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 (NYHA) Class ≥2; 3) Any arterial thrombosis, embolism, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or ) 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pucotenlimab · Drug: Becotatug vedotin · Radiation: Radiotherapy
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).
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).
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.
Pathologic response
Time frame: Periprocedural
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
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: At the end of every 2 treatment cycles (21-day cycle)
Plan to share: No
No publications or documents are linked to this record.
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Studies of the drug tested here: Becotatug vedotin
Squamous Cell Carcinoma of Head and Neck →
Jiangsu Cancer Institute & Hospital