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

NCT ID: NCT06498986

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-08-31

Brief Summary

This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed 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

BL-B01D1+Osimertinib Mesylate Tablets

Participants receive BL-B01D1+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 for a cycle of 3 weeks.

Osimertinib Mesylate Tablets

Intervention Type: DRUG

Oral administration, 80mg daily for a cycle of 3 weeks.

Interventions

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Osimertinib Mesylate Tablets

Oral administration, 80mg daily for a cycle of 3 weeks.

Intervention Type: DRUG

Other Intervention Names

iza-bren; izalontamab brengitecan; BMS-986507

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent and follow the requirements of the protocol;

2. No gender limit;

3. Age ≥18 years old;

4. Expected survival time ≥3 months;

5. Patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;

6. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;

7. Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing;

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

9. ECOG ≤1;

10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;

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

12. The level of organ function must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed;

13. Blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes acuities were 1.5 x ULN;

14. Urine protein ≤2+ or ≤1000mg/24h;

15. 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 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 prior systemic therapy;

2. Previous treatment with EGFR-TKI;

3. Participants who participated in any other clinical trial within 4 weeks before the trial dose;

4. Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeks before the first use of the study drug and had anti-tumor indications within 2 weeks before the first use of the study drug;

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

6. History of severe heart disease or cerebrovascular disease;

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

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

9. Previous history of interstitial lung disease requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;

10. Complicated 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. Other malignant tumors within 5 years before the first dose;

14. HIV 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. Severe unhealed wound, ulcer, or fracture within 4 weeks before consent signing;

21. Sign a four weeks before there were clinically significant bleeding or bleeding tendency obviously subjects;

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

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

24. A history of severe neurological or psychiatric illness;

25. Pregnant or lactating women;

26. Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;

27. 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

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

Caicun Zhou

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Caicun Zhou

Role: primary

Other Identifiers

BL-B01D1-207

Identifier Type: -

Identifier Source: org_study_id