Advanced solid tumor
Conditions
Interventions
Treatment group:BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnanc
Sponsors
The Second Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Who voluntarily sign the informed consent form to understand the nature, purpose and test procedures and can complete the test in accordance with the protocol; 2. Aged >= 18 (whichever is on the day of signing the informed consent), both male and female; 3. Patients with advanced or metastatic solid tumors diagnosed by pathological histology and / or cytology (cell wax only) who are unable for radical surgical resection, or who have failed to standard treatment or who have been intolerant to standard treatment (disease progression, or intolerant to chemotherapy, targeted therapy, etc.), or who lack effective treatment (Note: the Phase Ib dose extension study will limit a more specific population according to phase Ia test results, initially proposed as patients with advanced three-negative breast cancer and advanced pancreatic cancer); 4. According to the Response Evaluation Criteria in Solid Tumors of RECIST V1.1, the subject must have at least one measurable lesion; 5. Eastern ECOG physical status score =1.5x10^9/L; platelet count (PLT)>=100x10^9/L, hemoglobin content (HGB)>=9.0 g/dL(liver cancer patients with acceptable leukocyte count (WBC)>= 3.05 x 10^9/L, platelet count (PLT)>= 70 x 10^9/L); 2) Liver function: Serum total bilirubin (TBIL) =50mL/min, urinary protein =2+ should be collected in 24 hours of urine and <1g; in urine within 24 hours 8. The expected survival period exceeds 12 weeks; 9. Potential female subjects with blood must be negative (HCG) when entering this study; 10. Men with reproductive capacity or women likely to become pregnant (men or women without birth control surgery, and women without menopause) must use highly effective contraception (such as oral contraceptives, intrauterine contraceptives, abstinence or barrier control) during the trial and continue contraception for six months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Subject who has any active autoimmune disease or a history of autoimmune (subjects with vitiligo or complete remission of asthma in childhood without any intervention in adults; asthma requiring bronchodilator for medical intervention is not included); 2. A known history of primary immunodeficiency; 3. Suffering from interstitial lung disease, chemical pneumonia, allergic pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, acute pulmonary disease, etc. (except local stitial interstitial pneumonia induced by radiotherapy); 4. A history of active tuberculosis or tuberculosis; 5. Any active infection that requires systemic treatment through intravenous infusion within 14 days before randomization; 6. Two or more primary tumors remain present or present (excluding cured cervical in situ carcinoma, basal cell carcinoma or squamous cell skin cancer, and other tumors that have been treated for more than 5 years); 7. Known brain metastasis or other central nervous system metastasis with symptomatic or untreated treatment is not available in the group. However, CNS transfer that has been fully removed and stable or improved after / or radiotherapy can be enrolled, as long as imaging (CT/MRI) shows stabilization for at least 4 weeks before randomization and has no evidence of cerebral edema and no need for glucocorticoids or anticonvulsants; 8. Patients with hypertension who cannot in good control (systolic> 150mmHg or diastolic> 100mmHg); 9. Patients with any of the following heart diseases: current congestive heart failure or a severe arrhythmia requiiring treatment (except atrial fibrillation or paroxysmal supraventricular tachycardia) or unstable angina; ECG abnormalities: QTc (F) >= 480 ms or other ECG abnormalities that are not suitable for enrolling in the study judged by the investigator; 10. Patients with a history of myocardial infarction or T (TnT) were tested greater than 0.15 µg/L; 11. Have a history of mental illness; 12. Patients who are known to have severe allergic reactions to monomab (CTCAE v 5.0 grade> 3) and patients with an uncontrolled history of allergic asthma; 13. Those who had immunorelated adverse events (immune-related AE) grade >= 3 (according to CTCAE v 5.0); 14. People who have received systemic anti-tumor therapy or participated in other clinical studies and used other trial-related drugs 28 days before randomization, including chemotherapy, targeted therapy, immune therapy, biological therapy (tumor vaccines, cytokines, or growth factors that control cancer); 15. Major surgery was performed within 28 days before randomization or expected during the study, radiotherapy within 28 days before randomization, or therapeutic radioactive agents within 56 days prior to immediate enrollment; 16. A history of heterogeneous organ transplantation or a history of heterogeneous hematopoietic stem cell transplantation; 17. Traditional Chinese medicine decoction pieces or proprietary Chinese patent medicine that have received anti-tumor treatment within 7 days before randomly entering the group; 18. Persons prone to bleeding or undergoing thrombolytic or anticoagulant therapy (except for maintaining venous catheter); 19. Those who have been vaccinated within 3 months before signing the informed consent, or who intend to be vaccinated during the study period; 20. Those who had a history of blood donation within 3 months before signing the informed consent, or planned to donat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of various adverse events of DLT, evaluated per NCI CTCAE 5.0 standard, abnormal physical examination, vital signs, laboratory examination, 12-guided ECG, etc.; maximum tolerated dose (MTD).;Recommended Phase II clinical trial dose (RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Assessment;Immunogenicity assessment;Efficacy assessment; | — |
Countries
China
Contacts
Public ContactHuang Jian
The Second Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed