advanced tumors
Conditions
Interventions
Experimental group:PM1022 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. No gender limit, aged 18 to 75 years (boundary values included); 3. Subjects with malignant tumor confirmed by histology or cytology; 4. Adequate organ function; 5. ECOG score was 0-1; 6. Expected survival >=12 weeks; 7. According to RECIST1.1, there are at least one evaluable or measurable tumor lesion; 8. All subjects should undergo biopsy of tumor lesions during the screening; if biopsy is not possible, formalin-fixed-paraffin-embedded (FFPE)-processed tumor samples closest to the start of study treatment should be provided for biomarker analysis; 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 5 months from the date of signing the informed consent form to the end of the last medication; 10. Male subjects are willing to remain abstinent from sex or use medically approved highly effective contraception from the time of signing the informed consent to 5 months after the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Previous exposure to immune costimulatory molecule agonists or immune checkpoint inhibitors of patients in phase I; 3. Patients who have grade >=3 immune-mediated adverse event that associated with a prior immunotherapy; 4. Adverse reactions to previous antitumor therapy have not recovered to NCI-CTCAE V5.0 rating 38.5°C during the screening or before the initiation of study treatment (fever caused by tumor can be included according to the investigator); 14. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 15. History of alcohol, psychotropic substance or drug abuse; 16. History of psychiatric disorders or poor compliance; 17. History of immunodeficiency, including a positive HIV antibody test; 18. Patients with active syphilis infection; 19. Patients with active hepatitis B or C; 20. According to the investigator, the underlying condition of the patient may increase the risk of receiving the investigational drug, or cause confusion for the interpretation of the toxic reaction and AE. 21. Pregnant or lactating patients; 22. Other conditions considered unsuitable for this study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity occurred within 21 days after first administration;Objective response rate of phase IIa; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristic;Maximum tolerated dose;Treatment related adverse event;Recommended phase ? dose;Progress free survial;Overall survival;Disease control rate;Anti-drug antibody; | — |
Countries
China
Contacts
Public ContactGuo Ye
Shanghai East Hospital (South Campus)
Outcome results
None listed