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
- Registration Number
- NCT06437522
- Lead Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria:<br><br> 1. Subject volunteered to participate in the study and signed an informed consent;<br><br> 2. Male or female aged =18 years and =75 years;<br><br> 3. Expected survival time =3 months;<br><br> 4. ECOG score 0-1;<br><br> 5. Patients with recurrent or metastatic head and neck squamous cell carcinoma<br> (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology<br> and/or cytology;<br><br> 6. Patients must provide a documented tumor tissue specimen of the primary or<br> metastatic tumor within 3 years for PD-L1 testing and other testing;<br><br> 7. At least one measurable lesion meeting the RECIST v1.1 definition was required;<br><br> 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs<br> within 14 days before screening, and the organ function level must meet the<br> requirements;<br><br> 9. The toxicity of previous antineoplastic therapy has returned to = grade 1 as defined<br> by NCI-CTCAE v5.0;<br><br> 10. For premenopausal women of childbearing potential, a pregnancy test must be<br> performed within 7 days before the initiation of treatment, a serum or urine<br> pregnancy test must be negative, and the patient must not be lactating; All enrolled<br> patients should take adequate barrier contraception during the entire treatment<br> cycle and for 6 months after the end of treatment.<br><br>Exclusion Criteria:<br><br> 1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin;<br><br> 2. Before the first delivery within four weeks or five half-life used anti-tumor<br> treatment; Palliative radiotherapy was given within 2 weeks before the first dose;<br><br> 3. Received any previous systemic antitumor regimen for solid tumors such as recurrent<br> or metastatic head and neck squamous cell carcinoma;<br><br> 4. Had received immunotherapy and developed = grade 3 irAE or = grade 2 immune-related<br> myocarditis;<br><br> 5. Use of an immunomodulatory drug within 14 days before the first dose of study drug;<br><br> 6. Systemic corticosteroids were required within 2 weeks before the first dose of the<br> study;<br><br> 7. Has a history of severe disease of heart head blood-vessel;<br><br> 8. Active autoimmune and inflammatory diseases;<br><br> 9. Other malignant tumors that progressed or required treatment within 3 years before<br> the first dose;<br><br> 10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;<br><br> 11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b)<br> poorly controlled hypertension; c) history of hypertensive crisis or hypertensive<br> encephalopathy;<br><br> 12. Unstable thrombotic events requiring therapeutic intervention within 6 months before<br> screening;<br><br> 13. Patients with active central nervous system metastasis;<br><br> 14. Patients with pleural effusion, pericardial effusion or ascites with clinical<br> symptoms or requiring repeated drainage;<br><br> 15. Had allergic history to recombinant humanized antibody or human-mouse chimeric<br> antibody or to any of BL-B01D1's excipients;<br><br> 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation<br> (Allo-HSCT);<br><br> 17. Human immunodeficiency virus antibody positive, active tuberculosis, active<br> hepatitis B virus infection or active hepatitis C virus infection;<br><br> 18. Active infection requiring systemic therapy;<br><br> 19. Had participated in another clinical trial within 4 weeks before the first dose;<br><br> 20. Who have a history of psychotropic drug abuse and cannot abstain from it or have<br> mental disorders;<br><br> 21. Other circumstances that the investigator deemed inappropriate for participation in<br> the trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR);Recommended Phase II Dose (RP2D)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS);Disease Control Rate (DCR);Duration of Response (DOR);Treatment Emergent Adverse Event (TEAE)