- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929080
The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC
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
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Yajie Wang
- Phone Number: 02161058800
- Email: yajie_wang@junshipharma.com
Study Locations
-
-
-
Chengdu, China
- Sichuan Cancer hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
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;
Exclusion criteria:
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;
- 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."
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JS004 200mg, Q3W until to 2 years
Part A: phase I: 3-6; phase II: 66.
|
200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
|
Experimental: JS004 600mg, Q3W until to 2 years
Part A: phase I: 3-6; phase II: 66.
|
200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
|
Experimental: 240mg JS001+100mg JS004, Q3W until to 2 years
Part B: phase I: 6; phase II: 68.
|
200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001
|
Experimental: 240mg JS001+200mg JS004, Q3W until to 2 years
Part B: phase I: 6; phase II: 68.
|
200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
ORR evaluated according to RECIST 1.1
Time Frame: 2 years
|
Objective Response Rate(ORR) evaluated according to RECIST 1.1
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 2 years
|
Maximum Plasma Concentration(Cmax) after injection of JS004
|
2 years
|
OS
Time Frame: 2 years
|
Overall survival
|
2 years
|
DOR
Time Frame: 2 years
|
Duration of Response
|
2 years
|
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
Time Frame: 2 years
|
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
|
2 years
|
DCR
Time Frame: 2 years
|
Disease Control Rate (DCR)
|
2 years
|
ADA/Nab rate
Time Frame: 2 years
|
the rate of Anti-drug body (ADA) and neutralizing antibody (Nab)
|
2 years
|
PFS
Time Frame: 2 years
|
Progression-free survival evaluated according to RECIST 1.1
|
2 years
|
6-month OS rate
Time Frame: 6 months
|
6-month overall survival rate
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 2 years
|
Perk Time(Tmax) after injection of JS004
|
2 years
|
Predictive biomarkers
Time Frame: 2 years
|
Predictive biomarkers, including but not limited to, BTLA and HVEM
|
2 years
|
Ctrough
Time Frame: 2 years
|
trough Plasma Concentration (Ctrough) after injection of JS004
|
2 years
|
AUC
Time Frame: 2 years
|
Area Under the Cure(AUC) after injection of JS004
|
2 years
|
t1/2
Time Frame: 2 years
|
t1/2 after injection of JS004
|
2 years
|
Plasma Clearence(CL)
Time Frame: 2 years
|
Plasma Clearence(CL) after injection of JS004
|
2 years
|
volume of distribution of steady state(Vss)
Time Frame: 2 years
|
volume of distribution of steady state(Vss) after multiple dose injection of JS004
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Immunoglobulin G
Other Study ID Numbers
- JS004-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasopharyngeal Carcinoma
-
National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
-
National Cancer Institute (NCI)CompletedRecurrent Nasopharynx Carcinoma | Stage III Nasopharyngeal Carcinoma AJCC v7 | Stage IV Nasopharyngeal Carcinoma AJCC v7 | Stage IVA Nasopharyngeal Carcinoma AJCC v7 | Stage IVB Nasopharyngeal Carcinoma AJCC v7 | Stage IVC Nasopharyngeal Carcinoma AJCC v7 | Nasopharyngeal Nonkeratinizing CarcinomaUnited States, Singapore, China
-
National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal...United States, Canada
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing... and other conditionsUnited States, Canada, Australia
-
Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
-
Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownLOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNTFrance
-
Stanford UniversityTerminatedStage IV Nasopharyngeal Carcinoma | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma | Stage II Nasopharyngeal Carcinoma | Stage 0 Nasopharyngeal Carcinoma | Stage 0 Paranasal Sinus Cancer | Stage I Nasopharyngeal Carcinoma | Stage I Paranasal... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IV Nasopharyngeal Carcinoma AJCC v8 | Stage II Nasopharyngeal Carcinoma AJCC v8 | Stage III Nasopharyngeal Carcinoma AJCC v8
-
Cancer Institute and Hospital, Chinese Academy...RecruitingRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
Clinical Trials on JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
-
Shanghai Junshi Bioscience Co., Ltd.Active, not recruitingRecurrent/Refractory Malignant LymphomaChina
-
Shanghai Junshi Bioscience Co., Ltd.Unknown
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingMelanoma | Urothelial Carcinoma | Renal CarcinomaChina
-
Bio-Thera SolutionsNot yet recruiting
-
Shanghai Henlius BiotechHengenix Biotech Inc; Sanyou Biopharmaceuticals(Shanghai)Co., Ltd; Shanghai ZJ...Withdrawn
-
Sun Yat-sen UniversityShanghai Junshi Bioscience Co., Ltd.Unknown
-
Bio-Thera SolutionsTerminatedAdvanced Solid TumorAustralia
-
Beijing Mabworks Biotech Co., Ltd.RecruitingAdvanced or Metastatic Solid TumorChina
-
Bio-Thera SolutionsActive, not recruiting
-
Livzon Pharmaceutical Group Inc.Completed