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

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2026-06-30

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-B01D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

PD-1 monoclonal antibody

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

PD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Other Intervention Names

iza-bren; izalontamab brengitecan; BMS-986507

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaosu Hu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Dongmei Ji

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Chaosu Hu

Role: primary

Other Identifiers

BL-B01D1-204-02

Identifier Type: -

Identifier Source: org_study_id