advanced solid tumors
Conditions
Interventions
I:PM8002
IIa:PM8002
Sponsors
Shanghai Orient Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. Male or female aged 18 to 75 years; 3. Subjects with malignant tumor confirmed by histology or cytology; 4. All acute toxicity from prior antitumor therapy is reduced to level 0-1 or to an acceptable level for inclusion/exclusion criteria; 5. Adequate organ function; 6. ECOG score was 0-1; 7. Expected survival >=12 weeks; 8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally; 9. Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication; 10. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period; 11. Subjects shall provide tumor tissue specimens for PD-L1 analysis.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2. History of hypertensive crisis or hypertensive encephalopathy; 3. History of soft meningitis; 4. History of electrolyte disorders that cannot be corrected such as serum potassium, calcium or magnesium; 5. Evidence of major coagulopathy or other obvious risk of bleeding: 5.1) Patients with a history of intracranial hemorrhage or intraspinal hemorrhage; 5.2) Tumor lesions invade large blood vessels and have obvious bleeding risk (such as central lung squamous cell carcinoma); 5.3) History of thrombosis or embolism, or significant vascular disease (such as aortic aneurysm requiring surgical repair) within 6 months prior to the study treatment; 5.4) History of clinically significant hemoptysis or tumor bleeding by any cause within 1 month before screening; 5.5) Patients received anticoagulation therapy for therapeutic purposes (except low molecular weight heparin) within 2 weeks prior to the study treatment; 5.6) patients received antiplatelet drugs within 10 days prior to the study treatment; 5.7) Patients experienced needle biopsy or other minor surgery within 7 days prior to the study treatment, but the placement of the vascular infusion device; 6. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy; 7. At present patient with active tuberculosis; 8. Patients received immune checkpoint agonist therapy, or immune checkpoint inhibitor therapy; 9. Patients ever occurred= grade 3 toxicity related to anti-angiogenesis therapy; 10. Patients ever received the following treatments or drugs prior to the study treatment: 10.1) Major surgery performed within 28 days or has an unhealed wound, ulcer, or fracture; 10.2) Received live attenuated vaccine within 28 days prior to the study treatment; 10.3) Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments or received any other unmarketed study drugs within 28 days prior to the study treatment; 10.4) Received systemic immunostimulant therapy (such as interferon-a, interleukin-2) within 28 days prior to the study treatment or are still within 5 half-lives of the therapeutic drug (whichever is longer); 10.5) Received intravenous broad-spectrum antibiotic treatment within 2 weeks prior to the study treatment; 10.6) Received immunosuppressive drug therapy (such as corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF-a drugs) within 2 weeks prior to the study treatment; 10.7) Long-term daily treatment with non-steroidal anti-inflammatory drugs (NSAID) (occasionally used to relieve symptoms of disease, such as headache or fever). 11. Known metastases to the meninges, or uncontrollable or symptomatic central nervous system (CNS) metastases; 12. Patients with active autoimmune disease or a history of autoimmune disease with expectations to relapse; 13. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment; 14. Patients ever experienced the following conditions within 6 months prior to the study treatment: myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident/stroke, and cardiac dysfunction with grade 2 or above in the NYHA classification; 15. Patients with history of abdominal fistula, tracheoesophageal fi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT occurred within 21 days after first administration;ORR; | — |
Countries
China
Contacts
Public ContactYe Guo
Shanghai Orient Hospital
Outcome results
None listed