A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT ID: NCT05880706

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2027-07-31

Brief Summary

A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Study Design

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

Study Groups

Study treatment

Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets in 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

Osimertinib Mesylate Tablets

Intervention Type: DRUG

Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.

Interventions

BL-B01D1

Administration by intravenous infusion

Intervention Type: DRUG

Osimertinib Mesylate Tablets

Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.

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. Gender is not limited;

3. Age ≥18 years old;

4. Expected survival time ≥3 months;

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

6. Consent to provide an archived tumor tissue sample or fresh tissue sample from the primary or metastatic site within 6 months for biomarker testing;

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

8. ECOG ≤1;

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

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The level of organ function must meet the requirements on the premise that no blood transfusion and no use of any cell growth factor drugs are allowed within 14 days before the screening period;

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

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 6 months after the first dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria

1. Patients with previous systemic therapy;

2. Cohort_B and Cohort_C were previously treated with EGFR-TKI;

3. Who had participated in any other clinical trial within 4 weeks before the study dose;

4. Received chemotherapy, radiotherapy, biological therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of study drugs;

5. Had undergone major surgery within 4 weeks before the first dose;

6. History of severe heart disease and cerebrovascular disease;

7. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;

8. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;

9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;

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

11. Severe systemic infection within 4 weeks before screening;

12. Patients at risk for active autoimmune disease or with a history of autoimmune disease;

13. Complicated with other malignant tumors within 5 years before the first dose of medication;

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

15. Hypertension poorly controlled by two antihypertensive drugs;

16. Patients with poor glycemic control;

17. Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;

18. Patients with active central nervous system metastases;

19. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;

20. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;

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

22. Previous history of allogeneic stem cell, bone marrow or organ transplantation;

23. Patients with a history of allergy to recombinant humanized antibody or to any of the excipients of BL-B01D1;

24. Had a history of severe neurological or psychiatric disorders;

25. Had a history of autologous or allogeneic stem cell transplantation;

26. Pregnant or lactating women;

27. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;

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

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

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caicun Zhou, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BL-B01D1-203

Identifier Type: -

Identifier Source: org_study_id