Advanced tumor
Conditions
Interventions
treatment group:PM1009 injection
Sponsors
Shanghai Orient Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients participate in the study voluntarily and sign informed consent; 2. Male or female, aged 18-75 years (including boundary value); 3. Subjects with advanced tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment scheme, or standard treatment is not applicable at this stage; 4. Having adequate organ function; 5. ECOG score is 0-1; 6. Expected survival >= 12 weeks; 7. There is at least one assessable tumor focus.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic; 2. Those who have received anti-TIGIT or anti-PVRIG therapy in the past; 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 <= 1; 5. Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy; 6. Patients ever received the following treatments or drugs prior to the study treatment: (1) Major organ surgery within 28 days prior to initiation of trial treatment; (2) Received live attenuated vaccine within 28 days prior to the study treatment; (3) Received antitumor therapy within 4 weeks prior to the study treatment; (4) Received systemic glucocorticoid within 14 days prior to the study treatment; 7. Active infection was present within 14 days before starting study treatment; 8. Those with known uncontrolled parenchymal or leptomeningeal metastases; 9. Patients with active autoimmune disease or a history of autoimmune disease with potential for relapse; 10. Patients with other active malignancies within 5 years prior to initiation of study treatment, except for locally treatable and cured malignancies; 11. History of severe cardiovascular and cerebrovascular diseases; 12. Patients with uncontrolled tumor-related pain; 13. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 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. Pregnant or lactating women; 21. Other conditions considered unsuitable for this study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of DLT(dose limited toxicity) within 21 days after the first dose;Objective Response Rate;anti-drug antibody;Disease control rate; Progress free survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined Recommended Phase II Dose of PM1009;Treatment related adverse event;Pharmacokinetic characteristic; | — |
Countries
China
Contacts
Public ContactYe Guo
Outcome results
None listed