Status:
TERMINATED
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05427396
Start Date
July 28 2022
End Date
January 15 2024
Last Update
December 3 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China