Melanoma and Urothelial Carcinoma
Conditions
Interventions
monotherapy:QLF31907 intravernous infusion
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated and signed a written informed consent form 2. Age >= 18 years, male or female 3. ECOG performance status of 0 or 1 4. Expected life-expectancy >= 3 months 5. Histologically confirmed diagnosis of locally advanced or metastatic unresectable melanoma or urothelial carcinoma, failed or intolerant or rejected to standard therapy 6. Subjects must have at least one measurable lesion according to RECISTv1.1 7. Adequate organ function prior to QLF31907 administration 8. All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 180 days after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose
Exclusion criteria
Exclusion criteria: 1. Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein 2. Known to be allergic to any excipients of QLF31907 or a history of severe allergic reactions to other monoclonal antibodies 3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or autologous stem cell transplantation within 180 days 4. Known history of cytotherapy or antitumor vaccine within 4 weeks 5. Known history of antitumor therapy within 4 weeks 6. Known history of other drug or device clinical research within 4 weeks 7. Known history of major organ surgery or significant trauma, or elective surgery expected during the trial within 4 weeks 8. Known history of systemic glucocorticoid therapy or other immunosuppressants within 14 days 9. Active central nervous system (CNS) metastases 10. Known history of other active malignant tumor within 3 years, unless completely cured 11. With uncontrolled or clinically symptomatic pleural, pericardial or abdominal effusions 12. An active infectious disease requiring intravenous antibiotic therapy 13. Failure to recover to grade 1 from adverse reactions due to prior treatment according to CTCAE v5.0 14. An active autoimmune diseases or known history of = grade 3 irAE due to prior immunotherapy 15. Known history of severe cardiovascular and cerebrovascular disease 16. Known history of idiopathic pulmonary fibrosis, pneumoconiosis, asbestosis (including drug-induced lung injury) 17. Poorly controlled respiratory, circulatory or endocrine diseases 18. Known history of hepatitis (non-alcoholic steatohepatitis, alcoholic or autoimmune hepatitis) and cirrhosis 19. Active hepatitis B virus or hepatitis C virus infection 20. Active tuberculosis or active syphilis 21. Known history of human immunodeficiency virus (HIV) infection, or other acquired or congenital immunodeficiency disease 22. Known history of psychotropic substance abuse, alcohol or drug abuse, or definite neurological or psychiatric disorders including epilepsy or dementia 23. Subjects who are breastfeeding 24. Other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and subjects who are not suitable for participation in this study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Adverse Events;Serious adverse events;Treatment-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of remission;Disease control rate;time to progression;progression free survival;overall survival;Pharmacokinetic parameters;Immunogenicity;safety; | — |
Countries
China
Contacts
Public ContactJun Guo
Beijing Cancer Hospital
Outcome results
None listed