A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection… (NCT05427396) | Clinical Trial Compass
TerminatedPhase 1
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
Stopped: 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
China31 participantsStarted 2022-07-28
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
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);
What they're measuring
1
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
✕. 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