a study of bl-b16d1 in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors

Conditions: Head and Neck Squamous Cell Carcinomas; Solid Tumor

Summary: this study is an open, multicenter, increasing dose and dose extension nonrandomized phase i clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of bl-b16d1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old (phase ia); ≥18 years old (phase ib); 4. expected survival time ≥3 months; 5. patients with pathologically and/or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors who failed or could not receive standard treatment; 6. agreed to provide primary tumors or metastases 3 years archive of tumor tissue samples or fresh tissue samples; 7. must have at least one accord with recist v1.1 define measurable lesions; 8. ecog physical status 0 or 1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. the organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening; 12. blood coagulation function: international standardization ratio (inr) 1.5 or less, and the part activated clotting time (aptt) live enzymes uln 1.5 or less; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; all the patients (no matter male or female) shall be 6 months after the end of the treatment period and adequate precautions. exclusion criteria: 1. antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 2. history of severe heart disease; 3. qt prolongation, complete left bundle branch block, iii degree atrioventricular block; 4. active autoimmune and inflammatory diseases; 5. before the first delivery within 5 years diagnosed as other malignant tumor; 6. hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 7. patients with poor glycemic control; 8. present with grade ≥1 radiation pneumonitis according to the rtog/eortc definition; previous history of ild or current ild, or suspicion of such disease during screening; 9. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 10. there is activity of the central nervous system symptoms; 11. patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of bl-b16d1; 12. before transplant or allogeneic hematopoietic stem cell transplantation (allo - hsct); 13. previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs \> 360 mg/m2; 14. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 15. severe infection occurred within 4 weeks before the first dose; signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose; 16. patients with massive or symptomatic effusions or poorly controlled effusions; 17. had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose); 18. had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. contact lens dependence; e. uncontrolled glaucoma; f. uncontrolled or progressive retinopathy, wet macular degeneration, etc.; 19. other circumstances that the investigator deemed inappropriate for participation in the trial.