a study of bl-b01d1+pd-1 monoclonal antibody in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this study is a phase ii clinical study to explore the efficacy and safety of bl-b01d1 + pd-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. subject volunteered to participate in the study and signed an informed consent; 2. male or female aged ≥18 years and ≤75 years; 3. expected survival time ≥3 months; 4. ecog score 0-1; 5. patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology; 6. patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for pd-l1 testing and other testing; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. no blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. for premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a 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 treatment with an adc drug with top i inhibitors as a toxin; 2. before the first delivery within four weeks or five half-life used anti-tumor treatment; palliative radiotherapy was given within 2 weeks before the first dose; 3. received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma; 4. had received immunotherapy and developed ≥ grade 3 irae or ≥ grade 2 immune-related myocarditis; 5. use of an immunomodulatory drug within 14 days before the first dose of study drug; 6. systemic corticosteroids were required within 2 weeks before the first dose of the study; 7. has a history of severe disease of heart head blood-vessel; 8. active autoimmune and inflammatory diseases; 9. other malignant tumors that progressed or required treatment within 3 years before the first dose; 10. with ild requiring steroid treatment, current ild, or suspected ild at screening; 11. presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy; 12. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 13. patients with active central nervous system metastasis; 14. patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage; 15. had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of bl-b01d1's excipients; 16. prior organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 17. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 18. active infection requiring systemic therapy; 19. had participated in another clinical trial within 4 weeks before the first dose; 20. who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; 21. other circumstances that the investigator deemed inappropriate for participation in the trial.