Head and Neck Squamous Cell CarcinomPhase 1/2NCT04929080
The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC
A Phase 1/2 study testing JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and JS001 and JS004 in people with Head and Neck Squamous Cell Carcinom and Nasopharyngeal Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinom, Nasopharyngeal Carcinoma
- What is being tested?
- JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and JS001 and JS004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 6 Mar 2023
- 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.Males and females ≥ 18 and ≤ 80 years of age; 2.Recurrent or metastatic squamous cell carcinoma of the head and neck and nasopharyngeal carcinoma confirmed histologically or cytologically are no longer suitable for local treatment such as surgery or radiotherapy； 3.Has received at least a first-line standard regimen for relapsed and metastatic disease and has progressed during or after treatment; 4.The Eastern Cooperative Oncology Group (ECOG) had a physical status score of 0 or 1. 5.Life expectancy ≥12 weeks; 6.At least one measurable lesion per RECISTv1.1 and iRECIST; 7.Willingness to provide consent for fresh pre-treatment biopsies, or,an archival specimen could be required within two years prior to the first dose of study drug; 8.Adequate organ and marrow function per protocol specifically defined; 9.Females of childbearing potential ,and males who are sexually active with a female partner of childbearing potential, must use effective contraception from time of screening, and must agree to continue using such precautions for 60 days after the final dose of JS004; 10.All acute toxic reactions caused by previous anti-tumor therapy, surgery or radiotherapy were alleviated to grade 0-1 (according to NCI-CTCAE version 5.0) or to the level specified by the inclusion/exclusion criteria.Except for hair loss, pigmentation, or other toxicity that the researcher believes does not pose a safety risk to the subject, and does not affect treatment compliance. 11.Able to understand and willing to sign the Informed Consent Form;
Who cannot join
- 1.This is a histologically or cytologically confirmed salivary adenocarcinoma or other non-squamous cell carcinoma;nasopharyngeal carcinoma is not applicable. 2.Previously received anti-BTLA or anti-HVEM antibody treatment. 3.There are necrotic lesions, and the investigator has assessed the risk of hemorrhage 4.Other malignancies were diagnosed within 5 years prior to study entry; 5.There are uncontrolled or symptomatic active central nervous system (CNS) metastases; 6.Poor control of pleural effusion, peritoneal effusion, or pericardial effusion; 7.Peripheral neuropathy or hearing loss≥Grade 2 (according to NCI-CTCAE 5.0); 8.Pregnant or breastfeeding women.
- 9.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.Idiopathic pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function. 11.The following conditions occurred within 6 months before the first study administration: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestion Heart failure 12.Poorly controlled hypertension; hypertensive crisis or hypertensive encephalopathy occurred within 6 months of the first administration; 13. Those who are known to be allergic to the study drug or any of its excipients, or have severe allergic reactions to other monoclonal antibodies; 14. Have received the following drugs or treatments before the first study drug treatment:
- Major surgery has been performed within 28 days before the first study administration.
- Received systemic anti-tumor therapy within 28 days before the first study administration;
- Participated in other intervention studies within 28 days before the first study dose;
- Received systemic immunomodulatory drug treatment within 14 days before the first study administration or within 5 half-lives of the drug;
Show all 10Show fewer
- Received systemic corticosteroids or other systemic immunosuppressants within 14 days before the first study administration;
- Received oral or intravenous antibiotic treatment within 14 days before the first study administration (except for the case of prophylactic use of antibiotics);
- Any live vaccine has been vaccinated within 28 days before the first study administration; 15. Have a history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, blood vessel thrombosis related to antiphospholipid syndrome Formation, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis; 16. Severe infections (NCI-CTCAE> level 2) occurred within 28 days before the first study administration, such as severe pneumonia, bacteremia, and infectious comorbidities that require hospitalization.
- 17. Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical routines), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive) ； 18. The presence of other serious physical or mental illnesses or abnormal laboratory tests, or alcoholism, drug abuse, etc., may increase the risk of participating in the study, affect treatment compliance, or interfere with the results of the study, and other cases determined by the investigator to be unsuitable for participation Patients in this study."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Study of JS004, a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA), in Subjects With Head and Neck Cancer
A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.
- Being tested
- JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion, JS001 and JS004
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusionBiological
200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusionBiological
600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
JS001 and JS004Biological
Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001
| Study group | Role | What they receive |
|---|---|---|
| JS004 200mg, Q3W until to 2 years | Experimental | Part A: phase I: 3-6; phase II: 66. Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion |
| JS004 600mg, Q3W until to 2 years | Experimental | Part A: phase I: 3-6; phase II: 66. Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion |
| 240mg JS001+100mg JS004, Q3W until to 2 years | Experimental | Part B: phase I: 6; phase II: 68. Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Biological: JS001 and JS004 |
| 240mg JS001+200mg JS004, Q3W until to 2 years | Experimental | Part B: phase I: 6; phase II: 68. Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Biological: JS001 and JS004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
Measured: 2 years
ORR evaluated according to RECIST 1.1
Objective Response Rate(ORR) evaluated according to RECIST 1.1
Measured: 2 years
Secondary outcomes (8)
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
Measured: 2 years
DCR
Disease Control Rate (DCR)
Measured: 2 years
ADA/Nab rate
the rate of Anti-drug body (ADA) and neutralizing antibody (Nab)
Measured: 2 years
Cmax
Maximum Plasma Concentration(Cmax) after injection of JS004
Measured: 2 years
DOR
Duration of Response
Measured: 2 years
PFS
Progression-free survival evaluated according to RECIST 1.1
Measured: 2 years
OS
Overall survival
Measured: 2 years
6-month OS rate
6-month overall survival rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start11 May 2021
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929080
- Sponsor's protocol ID
- JS004-004
- Status last verified
- Jul 2023
- First submitted
- 10 May 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of JS004, a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA), in Subjects With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04929080
- Acronym / sponsor ID
- JS004-004
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 18 Jun 2021 (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.
A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JS004 200mg, Q3W until to 2 years | Experimental | Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusionPart A: phase I: 3-6; phase II: 66. |
| JS004 600mg, Q3W until to 2 years | Experimental | Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusionPart A: phase I: 3-6; phase II: 66. |
| 240mg JS001+100mg JS004, Q3W until to 2 years | Experimental | Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion, Biological: JS001 and JS004Part B: phase I: 6; phase II: 68. |
| 240mg JS001+200mg JS004, Q3W until to 2 years | Experimental | Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion, Biological: JS001 and JS004Part B: phase I: 6; phase II: 68. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Males and females ≥ 18 and ≤ 80 years of age; 2.Recurrent or metastatic squamous cell carcinoma of the head and neck and nasopharyngeal carcinoma confirmed histologically or cytologically are no longer suitable for local treatment such as surgery or radiotherapy； 3.Has received at least a first-line standard regimen for relapsed and metastatic disease and has progressed during or after treatment; 4.The Eastern Cooperative Oncology Group (ECOG) had a physical status score of 0 or 1. 5.Life expectancy ≥12 weeks; 6.At least one measurable lesion per RECISTv1.1 and iRECIST; 7.Willingness to provide consent for fresh pre-treatment biopsies, or,an archival specimen could be required within two years prior to the first dose of study drug; 8.Adequate organ and marrow function per protocol specifically defined; 9.Females of childbearing potential ,and males who are sexually active with a female partner of childbearing potential, must use effective contraception from time of screening, and must agree to continue using such precautions for 60 days after the final dose of JS004; 10.All acute toxic reactions caused by previous anti-tumor therapy, surgery or radiotherapy were alleviated to grade 0-1 (according to NCI-CTCAE version 5.0) or to the level specified by the inclusion/exclusion criteria.Except for hair loss, pigmentation, or other toxicity that the researcher believes does not pose a safety risk to the subject, and does not affect treatment compliance. 11.Able to understand and willing to sign the Informed Consent Form;
Key exclusion criteria (10 listed)
- 1.This is a histologically or cytologically confirmed salivary adenocarcinoma or other non-squamous cell carcinoma;nasopharyngeal carcinoma is not applicable. 2.Previously received anti-BTLA or anti-HVEM antibody treatment. 3.There are necrotic lesions, and the investigator has assessed the risk of hemorrhage 4.Other malignancies were diagnosed within 5 years prior to study entry; 5.There are uncontrolled or symptomatic active central nervous system (CNS) metastases; 6.Poor control of pleural effusion, peritoneal effusion, or pericardial effusion; 7.Peripheral neuropathy or hearing loss≥Grade 2 (according to NCI-CTCAE 5.0); 8.Pregnant or breastfeeding women.
- 9.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.Idiopathic pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function. 11.The following conditions occurred within 6 months before the first study administration: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestion Heart failure 12.Poorly controlled hypertension; hypertensive crisis or hypertensive encephalopathy occurred within 6 months of the first administration; 13. Those who are known to be allergic to the study drug or any of its excipients, or have severe allergic reactions to other monoclonal antibodies; 14. Have received the following drugs or treatments before the first study drug treatment:
- Major surgery has been performed within 28 days before the first study administration.
- Received systemic anti-tumor therapy within 28 days before the first study administration;
- Participated in other intervention studies within 28 days before the first study dose;
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 |
|---|---|---|
| JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion | Biological | 240mg JS001+100mg JS004, Q3W until to 2 years, 240mg JS001+200mg JS004, Q3W until to 2 years, JS004 200mg, Q3W until to 2 years |
| JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion | Biological | JS004 600mg, Q3W until to 2 years |
| JS001 and JS004Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001 | Biological | 240mg JS001+100mg JS004, Q3W until to 2 years, 240mg JS001+200mg JS004, Q3W until to 2 years |
Primary outcome
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Time frame: 2 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
ORR evaluated according to RECIST 1.1
Time frame: 2 years
Objective Response Rate(ORR) evaluated according to RECIST 1.1
8 secondary outcomes
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
Time frame: 2 years
DCR
Time frame: 2 years
ADA/Nab rate
Time frame: 2 years
Cmax
Time frame: 2 years
DOR
Time frame: 2 years
PFS
Time frame: 2 years
OS
Time frame: 2 years
6-month OS rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and JS001 and JS004 in people with Head and Neck Squamous Cell Carcinom and Nasopharyngeal Carcinoma, 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 1 inclusion and 10 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 1 Aug 2023. 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?
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed (time frame: 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?
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 1 Aug 2023.