A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

NCT ID: NCT06475300

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2026-07-31

Brief Summary

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.

Conditions

Non-small Cell Lung Cancer; Nasopharyngeal Carcinoma; Solid Tumor

Study Design

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

Study Groups

BL-B01D1+PD-1 Monoclonal Antibody

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. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Any gender;

3. Age: ≥18 years old;

4. Expected survival time for 3 months or more;

5. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;

6. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. ECOG 0 or 1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

10. No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;

11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements;

12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;

13. The urine protein + 2 or 1000 mg / 24 h or less or less;

14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria

1. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;

2. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;

3. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Fluorouracil class oral drugs, etc.;

4. Serious heart disease;

5. Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;

6. Active autoimmune and inflammatory diseases;

7. Before the first delivery within 5 years diagnosed as other malignant tumor;

8. Two antihypertensive drugs poorly controlled hypertension;

9. Patients with poor glycemic control;

10. With a history of ILD, current ILD or suspected suffering from such diseases during screening;

11. Complicated with pulmonary diseases leading to severe respiratory function impairment;

12. There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;

13. Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;

14. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;

15. Active central nervous system of patients;

16. For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients;

17. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);

18. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;

19. Active infection requiring systemic therapy;

20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;

21. Had participated in another clinical trial within 4 weeks before the first dose;

22. Other conditions for trial participation were not considered appropriate by the investigator.

• Minimum Eligible Age: 18 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

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Li Zhang

Role: primary

Other Identifiers

BL-B01D1-204-05

Identifier Type: -

Identifier Source: org_study_id