NCT06437522 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
| NCT ID | NCT06437522 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-06-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-06-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Chaosu Hu
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06437522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06437522 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06437522 currently recruiting?
Yes, NCT06437522 is actively recruiting participants. Contact the research team at xiaosa@baili-pharm.com for enrollment information.
Where is the NCT06437522 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06437522 clinical trial?
NCT06437522 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. The principal investigator is Chaosu Hu at Fudan University. The trial plans to enroll 46 participants.