a study of bl-b01d1 + pd-1 in patients with locally advanced or metastatic urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: this study is a phase ii clinical study to explore the efficacy and safety of bl-b01d1 + pd-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.


Eligibility criteria:
inclusion criteria: 1. all subjects voluntarily participated in the study and signed informed consent; 2. male or female aged ≥18 years and ≤75 years; 3. expected survival time ≥3 months; 4. ecog 0-1; 5. unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and/or cytology; 6. participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer; 7. a biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for pd-l1 and other testing; 8. at least one measurable lesion meeting the recist v1.1 definition was required; 9. the level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and/or platelet-raising drugs are not allowed within 14 days before the first dose; 10. previous treatment-related toxicity returned to ≤ grade 1 defined by nci-ctcae v5.0; 11. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; all enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. prior adc recipients with topi inhibitors as toxin; 2. palliative radiotherapy within 2 weeks before the first dose; 3. prior immunotherapy with grade ≥3 irae or grade ≥2 immune-related myocarditis; 4. use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. the history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. active autoimmune and inflammatory diseases; 8. receiving \&gt before the first dose; long-term systemic corticosteroid therapy with prednisone 10mg/d; 9. other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. history of ild, current ild, or suspected ild; 12. complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; infusion-related thrombosis was excluded; 14. patients with active central nervous system metastases; 15. patients with massive or symptomatic effusions or poorly controlled effusions; 16. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. prior organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 18. hiv antibody positive, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 19. serious infection within 4 weeks before the first dose of study drug; signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. participated in another clinical trial within 4 weeks before the first dose; 21. patients with superior vena cava syndrome should not be rehydrated; 22. have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. other circumstances considered by the investigator to be inappropriate for participation in the trial.