Tumor
Conditions
Interventions
experimental group:BM001 injection
Sponsors
Luoyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All of the following conditions should be met at the same time 1. Male or female patients, aged 18-75 years; 2. Patients with advanced malignant tumors confirmed by pathology and / or cytology, such as liver cancer, ovarian cancer, prostate cancer, etc. 3. Patients with advanced solid tumors who failed or could not tolerate standard treatment; 4. Patients with ECOG 0-2; 5. Patients with an expected survival period of more than 3 months; 6. According to RECIST v1.1, the patient has at least one measurable or evaluable tumor lesion, and the longest diameter at baseline is more than or equal to 10 mm (if it is a lymph node, the shortest diameter is more than or equal to 15 mm). The lesion is suitable for intratumoral injection (the diameter of the lesion is at least 1 cm); 7. Patients with sufficient bone marrow reserve or without coagulation dysfunction of liver and kidney should have the following laboratory values: 8. Patients without brain metastases (except for patients with asymptomatic brain metastases, or patients with brain metastases but stable after treatment for more than 4 weeks); 9. The patients who signed the informed consent voluntarily had good expected compliance.
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions shall not be selected. 1. Subjects who are known or suspected to be allergic to the components of the study drug or its analogues; 2. Patients with any unstable or other diseases or medical conditions that may affect their safety or research compliance, and any serious or uncontrolled systemic diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active peptic ulcer, immune dysfunction, etc. 3. Patients with cardiovascular and cerebrovascular diseases / symptoms / indications meeting any of the following conditions: 4. Patients suffering from other malignant tumors or with a history of other malignant tumors, except for skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma which have been effectively controlled, non-invasive and have no recurrence and metastasis for 5 years; 5. Patients whose lesions could not meet the requirement of 1 ml intratumoral injection volume; 6. For women of childbearing age (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the results of serum pregnancy test were positive within 7 days before the first administration of the study drug; or, according to the judgment of the researchers, those who are willing to be pregnant, breast-feeding or unwilling to use effective contraceptive measures (including men) during the study period and within 3 months after the last administration of the study drug Subjects and their female spouses of childbearing age); 7. Within 4 weeks before the first administration of the study drug (1) Received chemotherapy, radiotherapy, biological / targeted drug therapy, immunotherapy and other anti-tumor treatment; (2) Major surgery; (3) Participated in other clinical trials, used or is using other experimental drug treatment (except for non intervention drug clinical trials); 8. Other severe, acute, or chronic clinical or mental illness or laboratory abnormalities that may increase the risk of research and research medication, or may interfere with the research results; 9. Patients with active autoimmune disease or history of autoimmune disease but may relapse, but patients with the following diseases are not excluded and can be further screened: (1) Type I diabetes; (2) Hypothyroidism (if controlled by hormone replacement therapy only); (3) Controlled celiac disease; (4) Skin diseases without systemic treatment (e.g. vitiligo, psoriasis, alopecia); (5) Any other disease that does not recur without external triggers; 10. Patients with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. 11. Patients who could not tolerate local injection of bm001; 12. The researcher thinks that the patient is not suitable to participate in this trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactWang Zhanhui
Luoyang Central Hospital
Outcome results
None listed