advanced solid tumors
Conditions
Interventions
I:PM8001 injection
IIa:PM8001 injection
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, as defined below: (1) Blood system: Neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=100x10^9/L; Hemoglobin (Hb) >=90g/L; (2) Liver function: Total bilirubin (TBIL) =50ml/min; If urinary protein >=2+, 24 hour urinary protein quantitative examination is required; if 24 hour urinary protein quantitative examination =12 weeks; 8. Pre-menopausal female subjects with negative blood pregnancy results before study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 5 months from the date of signing the informed consent form to the end of the last medication; 9. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 5 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; 10. Did not receive any Investigational Drug within 4 weeks prior to the treatment of the study; 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. Received immune therapy or treatment targeting TGF-beta; 3. The following treatments or drugs were administered prior to the treatment of the study: 1) Major surgery performed within 28 days or has an unhealed wound, ulcer, or fracture; 2) Used steroids or immunosuppressive drugs 14 days prior to the study treatment; 3) Live attenuated vaccine was administered within 28 days prior to the study treatment; 4) Received anti-tumor therapies within 28 days prior to the study treatment; The following conditions should also be excluded: treatment with nitrosourea or mitomycin C within 6 weeks prior to the study treatment; Oral fluorouracil and small-molecule targeted drug therapy 2 weeks prior to the study treatment or 5 half-lives of the drug, whichever is longer; received Chinese herbal medicine with anti-tumor indications 2 weeks prior to the study treatment; 5) Systemic antibiotic use >=7 days within 2 weeks prior to the study treatment; 4. Uncontrolled or symptomatic central nervous system metastases; 5. Had active autoimmune disease or a history of autoimmune disease with expectations to relapse; 6. Had other active malignant tumors within 5 years prior to the study treatment; 7. 6 months prior to the study treatment, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident/stroke, and cardiac dysfunction with grade 2 or above in the NYHA classification; 8. Uncontrollable pleural, pericardial and peritoneal effusion were found within 4 weeks prior to the study treatment; 9. Before starting the research treatment, existence of congenital long QT syndrome, use of cardiac pacemakers, left ventricular ejection fraction 480 msec, clinical significant arrhythmia and need interventions, myocardial troponin > 2.0 ULN, poorly controlled diabetes or hypertension; 10. unexplained fever of >38.5°C occurred during screening or prior to the study treatment; 11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. History of alcohol, psychotropic substance abuse or drug abuse; 13. History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.; 14. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome; 15. Syphilis antibody positive; 16. Hepatitis B virus carrier, hepatitis B subject stabilized after drug treatment, or hepatitis C subject cured; 17. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE; 18. Expect to receive any other form of antitumor drug therapy during the study; 19. Women who are pregnant or breastfeeding; 20. Other conditions lead to inappropriate to participate in this study as judged by the investigator.
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