A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
Primary Purpose
Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JS004
Toripalimab Injection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Sign the informed consent form voluntarily;
- Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
- Expected survival ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Patients with advanced solid tumors confirmed histologically or cytologically
- At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
- Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible;
- The patient has good organ function as indicated by screening laboratory results
- Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
- Good compliance and cooperated with the follow-up.
Exclusion Criteria:
- Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
- patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
- Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
- Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
- Central nervous system metastases and/or cancerous meningitis
- Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis
- A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
- Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure>140mmHg and/or diastolic pressure> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
- Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
- A positive result for human immunodeficiency virus (HIV) antibody test;
- Known active tuberculosis (TB).
- Live vaccine was administered within 4 weeks prior to 1st administration
- Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
- Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
- Pregnant or lactating woman;
- Known to be allergic to JS004 or toripalimab and its components;
- Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Sites / Locations
- Chinese PLA General HospitalRecruiting
- Chongqing University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
OS
Duration of Response
DOR
Duration of Response
DCR
Disease Control Rate
PFS
Progression-free survival
ORR
Overall Response Rate
TTR
Time to remission
TTP
time to progression
Full Information
NCT ID
NCT05427396
First Posted
June 5, 2022
Last Updated
September 20, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05427396
Brief Title
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
Official Title
A Phase I Clinical Study Evaluating the Safety, Tolerability,of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
JS004
Intervention Description
Usage and dosage: Inject 200mg once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Toripalimab Injection
Intervention Description
Usage and dosage: Inject 240mg once every 3 weeks
Primary Outcome Measure Information:
Title
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Description
Duration of Response
Time Frame
2 years
Title
DOR
Description
Duration of Response
Time Frame
2 years
Title
DCR
Description
Disease Control Rate
Time Frame
2 years
Title
PFS
Description
Progression-free survival
Time Frame
2 years
Title
ORR
Description
Overall Response Rate
Time Frame
2 years
Title
TTR
Description
Time to remission
Time Frame
2 years
Title
TTP
Description
time to progression
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
ORR
Description
Objective response rate based on iRECIST criteria (Version 2017);
Time Frame
2 years
Title
DOR
Description
duration of response based on iRECIST criteria (Version 2017);
Time Frame
2 years
Title
DCR
Description
disease control rate based on iRECIST criteria (Version 2017);
Time Frame
2 years
Title
PFS
Description
progression-free survival based on iRECIST criteria (Version 2017);
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign the informed consent form voluntarily;
Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
Expected survival ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Patients with advanced solid tumors confirmed histologically or cytologically
At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible;
The patient has good organ function as indicated by screening laboratory results
Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
Good compliance and cooperated with the follow-up.
Exclusion Criteria:
Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
Central nervous system metastases and/or cancerous meningitis
Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis
A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure>140mmHg and/or diastolic pressure> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
A positive result for human immunodeficiency virus (HIV) antibody test;
Known active tuberculosis (TB).
Live vaccine was administered within 4 weeks prior to 1st administration
Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
Pregnant or lactating woman;
Known to be allergic to JS004 or toripalimab and its components;
Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianming Xu, MD
Phone
86010-66939409
Email
jmxu2003@163.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, MD
Phone
86010-66939409
Email
jmxu2003@163.com
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhou, MD
Phone
86023-65456552
Email
qizhou9128@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
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