BL-M09D1 for people with advanced non-small cell lung cancer and other solid tumors

A Phase I Clinical Study 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

This trial will test whether BL-M09D1 is safe and can shrink tumors in adults with advanced non-small cell lung cancer or other solid tumors who have exhausted standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07056556 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase I trial uses a dose-escalation followed by cohort-expansion design to define the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BL-M09D1 given by injection. Eligible adults have histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer or other solid tumors that progressed after standard therapies, measurable disease per RECIST v1.1, and ECOG performance status 0–1. Participants must provide archived or fresh tumor tissue and meet cardiac, coagulation, and organ-function criteria. The non-randomized study will enroll sequential dose cohorts to identify a recommended dose for expansion and further study.

Who should consider this trial

Good fit: Ideal candidates are adults (Phase Ia 18–75 years; Phase Ib ≥18 years) with measurable, histologically confirmed locally advanced or metastatic non-small cell lung cancer or other solid tumors that have failed standard treatments, ECOG 0–1, expected survival ≥3 months, and who can provide recent tumor tissue.

Not a fit: Patients with poor organ function, significant cardiac dysfunction (LVEF <50%), uncontrolled coagulation abnormalities, ECOG ≥2, life expectancy under 3 months, or whose disease is controlled by standard therapies are unlikely to benefit.

Why it matters

Potential benefit: If successful, BL-M09D1 could provide a new treatment option that shrinks tumors or controls disease in patients with advanced solid tumors.

How similar studies have performed: Dose-escalation Phase I programs are a common first step and while some early-phase agents in solid tumors have shown promising signals, BL-M09D1 itself is a novel agent with no established clinical benefit yet.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Non-small Cell Lung Cancer; Solid Tumor