The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC

NCT ID: NCT04929080

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2023-03-06

Brief 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. 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.

Conditions

Head and Neck Squamous Cell Carcinom; Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS004 200mg, Q3W until to 2 years

Part A: phase I: 3-6; phase II: 66.

Group Type: EXPERIMENTAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

Intervention Type: BIOLOGICAL

200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

JS004 600mg, Q3W until to 2 years

Part A: phase I: 3-6; phase II: 66.

Group Type: EXPERIMENTAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

Intervention Type: BIOLOGICAL

600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

240mg JS001+100mg JS004, Q3W until to 2 years

Part B: phase I: 6; phase II: 68.

Group Type: EXPERIMENTAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

Intervention Type: BIOLOGICAL

200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

JS001 and JS004

Intervention Type: BIOLOGICAL

Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001

240mg JS001+200mg JS004, Q3W until to 2 years

Part B: phase I: 6; phase II: 68.

Group Type: EXPERIMENTAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

Intervention Type: BIOLOGICAL

200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

JS001 and JS004

Intervention Type: BIOLOGICAL

Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001

Interventions

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

JS001 and JS004

Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001

Intervention Type: BIOLOGICAL

Eligibility Criteria

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:

1. Major surgery has been performed within 28 days before the first study administration.

2. Received systemic anti-tumor therapy within 28 days before the first study administration;

3. Participated in other intervention studies within 28 days before the first study dose;

4. Received systemic immunomodulatory drug treatment within 14 days before the first study administration or within 5 half-lives of the drug;

5. Received systemic corticosteroids or other systemic immunosuppressants within 14 days before the first study administration;

6. Received oral or intravenous antibiotic treatment within 14 days before the first study administration (except for the case of prophylactic use of antibiotics);

7. 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."

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sichuan Cancer Hospital

Chengdu, , China

Countries

China

Other Identifiers

JS004-004

Identifier Type: -

Identifier Source: org_study_id