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Head and Neck Squamous Cell CancerPhase 1/2NCT04856631

A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer

A Phase 1/2 study testing Toripalimab Injection and Cetuximab Solution for infusion in people with Head and Neck Squamous Cell Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Cancer
What is being tested?
Toripalimab Injection and Cetuximab Solution for infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
6 Apr 2021to 25 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • 1.Patients voluntarily participate in this study after full informed consent and sign a written informed consent form;
  • 2.Age >=18 to <=75 years at time of consenting;
  • 3.Advanced, relapsed, or metastatic head and neck squamous cell carcinoma confirmed histologically or cytologically, occurring in the oral cavity, oropharynx, hypopharynx, larynx, or paranasal sinuses, and unsuitable for local therapy such as surgery or radiotherapy.
  • 4.Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease, and developing progressive disease during or after treatment; or receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy), and developing relapse or metastasis within 6 months after end of treatment.
  • 5.Phase II cohort B:
  • No previous systemic treatment for relapsed or metastatic disease. Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.
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  • Qualified tumor tissue samples with positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1) tested by the central laboratory are required.
  • 6. All acute toxic reactions from prior antitumor therapy, surgical procedures, or radiotherapy, etc., are relieved to Grades 0-1 (in accordance with NCI-CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Hair loss or pigmentation, or other toxicities that would not result in safety risk to subjects and would not influence compliance, as considered by the investigator, Are ruled out.
  • 7. Previous tumor samples or fresh tumor tissue biopsy samples may be provided.
  • 8 For subjects with oropharyngeal cancer, a prior test report for HPV16 may be provided, or eligible tumor tissue samples are provided to test HPV status.
  • 9. At least one measurable lesion in accordance with RECIST 1.1 assessment criteria;
  • 10 Patients with life expectancy >=12 weeks;
  • 11. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point;
  • 12. Good organ function level:
  • System organ Lab Value
  • Hematology (no blood transfusion or colony-stimulating factor or other drug correction within 14 days prior to the first study dose)
  • Neutrophil count ≥1.5×10^9/L
  • Platelet count ≥100×10^9/L
  • Hemoglobin ≥90 g/L
  • Kidney function
  • Serum creatinine <=1.5 x upper limit of normal (ULN) or Creatinine clearance is calculated with reference to the Cockcroft-Gault formula or the site practices ≥50 mL/min
  • Hepatic function
  • total Bilirubin <=1.5 x ULN or<=3 x ULN (patients with known Gilbert's disease)
  • ALT/AST <=3 x ULN (without liver metastasis) or<=5 x ULN (in case of liver metastases)
  • Albumin (no infusion of albumin product with 14 days prior to the first dose of the investigational medical product)≥30g/L
  • Coagulation function
  • International normalized ratio (INR)
  • Prothrombin Time (PT)
  • Activated Partial Thromboplastin Time (aPTT) <=1.5 x ULN
  • 13. Within 72 h prior to the first dose, for women of childbearing age must confirm that the serum pregnancy test is negative and agree to adopt effective contraceptive measures during use of the investigational medical product and for 5 months after last dose. A female of childbearing potential in this Protocol is defined as a sexually mature female who:
  • 1) No hysterectomy or bilateral oophorectomy, 2) Spontaneous menopause does not last for 24 consecutive months (amenorrhea after cancer treatment does not rule out fertility) (i.e., menstruation at any time within the previous 24 consecutive months).
  • Male patients with partners of childbearing potential must agree to use effective contraception during the use of the investigational medical product and for 5 months after last dose.

Who cannot join

  • Nasopharyngeal cancer or salivary gland cancer confirmed histologically or cytologically, or other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer), or metastatic squamous cell cancer with unknown primary site.
  • Patients with necrotic lesion, at risk for major hemorrhage as judged by the investigator.
  • Previously receiving other immune checkpoint inhibitors/drugs acting on immune checkpoint pathway/other drugs acting on T cell costimulation (e.g.: PD-1/PD-L1 antibody or CTLA-4 antibody);
  • Previous treatment of EGFR inhibitor (including radiotherapy sensitization therapy);
  • Diagnosed with other malignancies within 5 years prior to study entry, except for basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast that can be cured by local therapy
  • Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis, that may be characterized by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth;
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  • 1) Patients with asymptomatic spinal cord compression indicated radiologically may be enrolled, if assessed as stable by the specialist and requiring no treatment presently; 2) Patients who have previously received treatment for CNS metastases, and become stable for >=4 weeks as indicated radiologically in the screening period, and stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy may be enrolled;
  • 7. Poorly controlled hydrothorax, hydrops abdominis, or pericardial effusion;
  • 8. Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) peripheral neuropathy or hearing loss;
  • 9. Pregnant or breastfeeding female subjects;
  • 10. In the following cases within 6 months prior to the first dose: Myocardial infarction, serious/unstable angina, NYHA Grade >=2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure;
  • Note: Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be treated with an optimized stable medical regimen at the discretion of the treating physician, with consultation with a cardiologist, as appropriate;
  • 11. Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg) (based on the mean of >=3 BP readings obtained from >=2 measurements); hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose.
  • 12. Patients with known allergy to the investigational medical product or any excipient, or with serious allergic reaction to other monoclonal antibodies;
  • 13. Receiving the following drugs or therapies prior to first dose of investigational medical product :
  • Major surgery within 28 d prior to the first dose of the investigational therapy (tissue biopsy required for diagnosis, and pieripherally inserted central catheter [PICC] or infusion port implantation are permissible).
  • Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.) with 28 d prior to the first dose of the investigational medical product;
  • Participation in other intervention studies within 28 d prior to the first dose of the investigational medical product;
  • Treatment with a systemic immunostimulatory drug (including but not limited to interferon or IL-2) within 14 d or 5 half-lives of the investigational medicinal product (whichever is longer) prior to the first dose of the investigational medical product;
  • Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug) or other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF]) within 14 d prior to the first dose of the investigational therapy;
  • o Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted;
  • Patients receiving an acute low-dose systemic immunosuppressive agent (e.g., a single dose of dexamethasone for nausea, or preventive medication prior to administration of Cetuximab ) may be enrolled after discussion with and approval by the medical monitor;
  • Patients who need baseline and follow-up MRI/CT tumor assessment can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media.
  • Inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted;
  • Treatment of oral or intravenous antibiotic therapy (except preventive use of antibiotics) with 14 d prior to the first dose of the investigational therapy;
  • Vaccination of any live vaccine (e.g., vaccine against infectious diseases, such as influenza vaccine or varicella vaccine, etc.) within 28 d prior to the first dose of the investigational medical product;
  • 14. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis;
  • Patients with autoimmune-related hypothyroidism on a stable dose of thyroid hormone replacement are eligible;
  • Patients with type 1 diabetes who are controlled after receiving a stable insulin regimen are eligible for this study;
  • 15. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • 16. Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy, e.g., serious pneumonia requiring hospitalization, bacteremia, or infection complications, etc.
  • 17. Active infection, including but not limited to tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB screening according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);
  • Patients who are positive for hepatitis B surface antigen (HBsAg+) and/or hepatitis B core antibody (HBcAb+) are required to undergo hepatitis B virus deoxyribonucleic acid (HBV DNA) test. If HBV DNA copy number is ˂1000 cps/mL or <200 IU/mL, or less than the lower limit of detectable value at the study site, the patients are eligible to participate in this study;
  • Patients who are positive for hepatitis C antibody (HCV Ab+) are required to have an HCV RNA test and are eligible for this study only if they are negative for HCV RNA (defined as below the lower limit of detectable value at the research site);
  • 18. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e., bronchiolitis obliterans), clinically symptomatic radiation pneumonia or active pneumonia, or those requiring steroid therapy, or other moderate to severe pulmonary diseases influencing seriously pulmonary function.
  • 19. Patients with existing other serious physical or mental disorders or laboratory test abnormalities, or alcoholism or drug abuse, etc., that may increase the risk for participation in the study, influence compliance to the treatment, or interference the study results, or other conditions that are not suitable for participation in the study, as judged by the investigator

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai

Other trials in China

About this study

Official title: A Phase Ib/II, Single-arm, Multi-center Clinical Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer

This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the study phase II is divided into two cohorts. Cohort A used to evaluate the efficacy and safety of the combination of regimen for relapsed or metastatic HNSCC failing first-line platinum-based regimen containing chemotherapy;cohort B used to evaluate the efficacy and safety of the combination regimen for PD-L1-positive HNSCC that have not received prior systemic therapy for relapsed or metastatic disease.

Read the detailed description

This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the study phase II is divided into two cohorts. Cohort A used to evaluate the efficacy and safety of the combination of regimen for relapsed or metastatic HNSCC failing first-line platinum-based regimen containing chemotherapy;cohort B used to evaluate the efficacy and safety of the combination regimen for PD-L1-positive HNSCC that have not received prior systemic therapy for relapsed or metastatic disease.

The study consists of the screening period, treatment period, and follow-up period. The screening period is not more than 28 d; after completion of the examinations and assessment in the screening period, eligible subjects enter the investigational therapy period. The subjects will receive the investigational medical product in accordance with the Protocol until radiologically documented progressive disease as judged by the investigator in accordance with RECIST 1.1 criteria, intolerable toxicity, voluntary termination of the treatment or voluntary withdrawal of the informed consent by the subject, or termination of the treatment as judged by the investigator, or until 2 years of JS001 treatment duration (whichever occurs first).

Being tested
Toripalimab Injection, Cetuximab Solution for infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toripalimab InjectionDrug

    240mg once per 3 weeks

  • Cetuximab Solution for infusionDrug

    First infusion 400mg/m2，Subsequent infusions 250mg/m2。once per week

Study groups in NCT04856631
Study groupRoleWhat they receive
Experimental groupExperimentalToripalimab Injection (JS001) + Cetuximab
Receives: Drug: Toripalimab Injection; Drug: Cetuximab Solution for infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate(ORR)evaluated by RECIST 1.1-Phase2

    Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as objective response rate (ORR) evaluated

    Measured: Up to 2 years

  2. Incidence and severity of adverse event (AE) and serious adverse event (SAE)-Phase1

    Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0; and abnormalities in vital signs, ECG and laboratory tests, etc.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Objective response rate(ORR)evaluated by the investigator-Phase2

    Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC in accordance with RECIST 1.1, as objective response rate (ORR) evaluated by the investigator.

    Measured: Up to 2 years

  2. Disease control rate（DCR）and Duration of response（DOR）and progression-free survival (PFS).-Phase2

    Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC as disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).

    Measured: Up to 2 years

  3. Overall survival（OS）

    Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC as overall survival (OS) and 1-year OS

    Measured: Up to 2 years

  4. Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0

    Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0; and abnormalities in vital signs, ECG and laboratory tests, etc.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start6 Apr 2021
  3. Primary completion25 Oct 2024
  4. Study completion25 Oct 2024

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856631
Sponsor's protocol ID
JS001-037-Ib/II-HNSCC
Status last verified
Aug 2026
First submitted
14 Mar 2021
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo Y, Li Z, Xue L, Lin J, Qu S, Sun C, Fang M, Zhu Y, Zong J, Chen W, Cao G, Wu J, Ge M, Li Z, Wang S, Wang X, Jiang H, Hu D, Shen L, Wei Y, Jin C, Zhang H, Huang X, Sun Y, Shi J, Wang M, Luo X, Kuang S, Wei S, Deng R, Shen Y. Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study. Signal Transduct Target Ther. 2026 Jun 9;11(1):223. doi: 10.1038/s41392-026-02707-3.

    PubMed 42260304

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Toripalimab Injection and Cetuximab Solution for infusion in people with Head and Neck Squamous Cell Cancer, run by Shanghai Junshi Bioscience Co., Ltd. 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 32 inclusion and 36 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: finished, as of the sponsor's last update on 4 Aug 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR)evaluated by RECIST 1.1-Phase2 (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856631, which also lists 1 linked publication.

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 Aug 2026.

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