BL-M24D1 for adults with advanced or metastatic non-small cell lung cancer and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, non-randomized Phase I trial with a dose-escalation phase (Phase Ia) followed by a dose-expansion phase (Phase Ib). The study will monitor safety, tolerability, pharmacokinetics, and preliminary signs of anti-tumor activity of BL-M24D1. Eligible adults must have measurable disease per RECIST v1.1, ECOG performance status 0–1, adequate organ and coagulation function, and provide tumor tissue. Standard safety assessments and tumor evaluations will be used to identify appropriate dosing for expansion and to detect early efficacy signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Gender unrestricted;
3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
4. Expected survival time ≥3 months;
5. Locally advanced or metastatic non-small cell lung cancer and other solid tumors;
6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;
7. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
8. ECOG performance status score of 0 or 1;
9. Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Organ function levels must meet the requirements;
12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

Exclusion Criteria:

1. Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;
2. History of severe heart disease;
3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
4. Active autoimmune or inflammatory diseases;
5. Diagnosis of other malignancies within 5 years prior to the first dose;
6. Hypertension poorly controlled by two antihypertensive medications;
7. Poorly controlled blood glucose;
8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
9. Lung diseases graded ≥3 according to CTCAE v5.0;
10. Symptoms of active central nervous system metastasis;
11. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M24D1;
12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
13. Cumulative dose of anthracyclines \>360 mg/m² in previous (neo)adjuvant anthracycline therapy;
14. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
15. History of interstitial lung disease requiring hormonal treatment, or current ILD;
16. Active infection requiring systemic treatment within 4 weeks prior to the first investigational drug dose;
17. Pleural, peritoneal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first investigational drug dose;
18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first investigational drug dose;
19. Participation in another clinical trial within 4 weeks prior to the first dose;
20. Pregnant or lactating women;
21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.