A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

NCT ID: NCT07056556

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-12-31

Brief Summary

This study is an open-label, multicenter, dose-escalation and cohort-expansion, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.

Conditions

Non-small Cell Lung Cancer; Solid Tumor

Study Design

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

Study Groups

BL-M09D1

Participants receive BL-M09D1 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-M09D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

BL-M09D1

Administration by intravenous infusion for a cycle of 3 weeks.

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 (Phase Ia); ≥18 years (Phase Ib);

4. Expected survival time ≥3 months;

5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer or other solid tumors that have failed standard treatment;

6. Willing to provide archived or fresh tumor tissue samples from primary or metastatic lesions within the past 2 years;

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

8. ECOG performance status score of 0 or 1;

9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

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

11. Organ function levels must meet the requirements;

12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);

13. Urine protein ≤2+ or ≤1000mg/24h;

14. For premenopausal women with childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment completion;

15. The subject has the ability and willingness to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the protocol.

Exclusion Criteria

1. Received chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;

2. History of severe cardiac disease;

3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;

4. Active autoimmune or inflammatory diseases;

5. Diagnosed with another malignancy within 5 years before the first dose (except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix);

6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;

7. Poorly controlled hypertension;

8. Poorly controlled diabetes mellitus;

9. History of interstitial lung disease (ILD) requiring steroid therapy, current ILD, or ≥Grade 2 radiation pneumonitis;

10. Concurrent pulmonary diseases resulting in clinically severe respiratory impairment;

11. Active central nervous system metastases;

12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or hypersensitivity to any excipient of BL-M09D1;

13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

14. Cumulative dose of anthracyclines >360 mg/m² in prior (neo)adjuvant anthracycline therapy;

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

16. Active infections requiring systemic treatment within 4 weeks before the first study drug administration;

17. Pleural, peritoneal, pelvic, or pericardial effusion requiring drainage and/or symptomatic within 4 weeks before the first study drug administration;

18. Participation in another clinical trial within 4 weeks or 5 half-lives before the first dose;

19. Pregnant or lactating women;

20. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

• 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

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Shun Lu

Role: primary

Other Identifiers

BL-M09D1-102

Identifier Type: -

Identifier Source: org_study_id