Combination therapy for recurrent or metastatic head and neck cancer

A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors

This study is testing a new combination treatment for adults with recurrent or metastatic head and neck cancer to see if it helps them better than current options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06437522 on ClinicalTrials.gov

What this trial studies

This phase II clinical study investigates the efficacy and safety of a combination therapy using BL-B01D1 and PD-1 monoclonal antibodies in patients with recurrent or metastatic head and neck squamous cell carcinoma, as well as other solid tumors. Participants must be aged between 18 and 75 years and have a confirmed diagnosis of the targeted conditions. The study aims to evaluate the treatment's effectiveness based on measurable lesions and specific eligibility criteria, including prior treatment toxicity levels and organ function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic head and neck squamous cell carcinoma or other solid tumors.

Not a fit: Patients with nasopharyngeal carcinoma or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat head and neck cancers.

How similar studies have performed: Other studies have shown promise with similar monoclonal antibody approaches, indicating potential for success in this area.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Chaosu Hu — Fudan University
• Study coordinator: Sa Xiao, PHD

Conditions Head and Neck Squamous Cell Carcinoma