BL-M24D1 for adults with advanced or metastatic 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-M24D1 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

This trial will test whether BL-M24D1 is safe, how the body handles it, and whether it shows signs of benefit in adults with locally advanced or metastatic non-small cell lung cancer or other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07232420 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with locally advanced or metastatic non-small cell lung cancer or other solid tumors who have measurable disease, ECOG 0–1, adequate organ and coagulation function, and available archived or fresh tumor tissue are the intended candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), uncontrolled cardiac or significant organ dysfunction, unresolved high-grade toxicities from prior therapy, or without available tumor tissue are unlikely to qualify or benefit.

Why it matters

Potential benefit: If BL-M24D1 is safe and active, it could become a new treatment option for people with advanced non-small cell lung cancer or other solid tumors.

How similar studies have performed: This Phase I approach follows standard early development pathways; BL-M24D1 appears to be a novel agent with limited prior clinical data, while some other targeted or immune therapies have shown benefit in similar settings.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Non Small Cell Lung Cancer; Solid Tumor