A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
Reason given: The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
Key facts
- Phase
- Phase 1
This trial has no sites in United States.
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Trial details
- Who runs it
- Shanghai Junshi Bioscience Co., Ltd.
- Trial code
- NCT05427396
- Record updated
- 3 December 2025
- Original description
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.Read full original descriptionShow less
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
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.
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: 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; 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; 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); Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis; Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm; A positive result for human immunodeficiency virus (HIV) antibody test; Known active tuberculosis (TB); Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders; Known to be allergic to JS004 or toripalimab and its components; 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; 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 nervous system metastases and/or cancerous meningitis; A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment; Pregnant or lactating woman.