A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT ID: NCT05949606

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2027-12-31

Brief Summary

Phase Ib: To observe the safety and tolerability of the combination of SI-B001 and SI-B003, and to determine the recommended dose of phase II clinical study (RP2D) in the indication of locally advanced or metastatic non-small cell lung cancer. Phase II: To evaluate the efficacy of SI-B001+SI-B003 combination with or without chemotherapy 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 will receive treatment during the first cycle. Participants with clinical benefits received more cycles of additional therapy. Administration will be discontinued due to disease progression or occurrence of intolerable toxicity or other reasons.

Group Type: EXPERIMENTAL

SI-B001

Intervention Type: DRUG

Administration by intravenous infusion

SI-B003

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

SI-B001

Administration by intravenous infusion

Intervention Type: DRUG

SI-B003

Administration by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form and comply with the protocol requirements;

2. No gender restrictions;

3. Age ≥18 years and ≤75 years;

4. Expected survival time ≥3 months;

5. Subjects must agree to complete ctDNA testing during the screening period;

6. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) patients;

7. Agree to provide archived or fresh tumor tissue samples from primary or metastatic lesions;

8. Must have at least one measurable lesion as defined by RECIST v1.1;

9. Performance status score: ECOG ≤1;

10. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;

12. Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;

13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;

14. Urine protein ≤1+ or ≤1000 mg/24h;

15. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria

1. Prior to signing the informed consent form, relevant genetic alterations were indicated;

2. For patients enrolled in Phase II, any of the following conditions apply: a) Patients suitable for and willing to undergo local therapy; b) Patients who have received systemic chemotherapy;

3. Symptomatic brain parenchymal or leptomeningeal metastases, deemed ineligible by the investigator;

4. Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);

5. Use of chemotherapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose, or palliative radiotherapy, small-molecule targeted therapy, or other antitumor treatments within 2 weeks before the first dose;

6. Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;

7. Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;

8. Pulmonary diseases graded as ≥3 according to NCI-CTCAE v5.0; history of interstitial lung disease (ILD), current ILD, or suspected ILD during screening;

9. Concurrent pulmonary disease resulting in clinically significant respiratory impairment;

10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening (excluding catheter-related thrombosis);

11. Active infection requiring intravenous anti-infective therapy;

12. Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels, with a risk of bleeding post antitumor therapy;

13. Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;

14. Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;

15. Use of immunomodulatory drugs within 14 days before the first dose of the study drug;

16. Patients at risk of active autoimmune diseases or with a history of autoimmune diseases;

17. History of other malignancies within 5 years before the first dose;

18. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;

19. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);

20. History of severe cardiovascular or cerebrovascular diseases;

21. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;

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

23. History of hypersensitivity to recombinant humanized antibodies or any excipients of SI-B001 or SI-B003;

24. History of autologous or allogeneic stem cell transplantation;

25. Pregnant or lactating women;

26. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Caicun Zhou, PHD

Role: primary

Other Identifiers

SI-B001-SI-B003-202

Identifier Type: -

Identifier Source: org_study_id