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

RecruitingPhase 1Ages 18 Years - anyAllSichuan Baili Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • BL-M09D1
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Where

1 site
Shanghai Chest Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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