BL-M24D1 treatment for advanced gastrointestinal 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 Gastrointestinal Tumors and Other Solid Tumors

This trial will test BL-M24D1 in adults with locally advanced or metastatic gastrointestinal and other solid tumors to see if it is safe, tolerated, and shows early signs of anti-tumor activity.

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 (Beijing, Beijing Municipality)
• Trial ID: NCT07279428 on ClinicalTrials.gov

What this trial studies

This open-label, non-randomized Phase I trial gives BL-M24D1 by injection to adults with locally advanced or metastatic gastrointestinal tumors and other solid tumors. It includes a Phase Ia dose-escalation to determine safe dosing and pharmacokinetics, followed by a Phase Ib cohort expansion to look for preliminary signs of efficacy and further safety data. Key entry requirements include measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ and coagulation function, and provision of tumor tissue. Primary goals are safety and tolerability, with secondary assessment of drug levels and early anti-tumor activity.

Who should consider this trial

Good fit: Adults (≥18 years) with locally advanced or metastatic gastrointestinal or other solid tumors who have measurable disease, ECOG 0–1, adequate organ and coagulation function, and can provide tumor tissue are the intended candidates.

Not a fit: Patients with poor performance status, significant cardiac dysfunction, inadequate organ or coagulation function, rapidly declining condition, or without measurable disease are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, BL-M24D1 could provide a new treatment option that helps control or shrink tumors with an acceptable safety profile.

How similar studies have performed: Early-phase trials of novel cancer drugs sometimes show promising signals, but BL-M24D1 is an investigational agent and its effectiveness has not yet been established in prior studies.

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. Locally advanced or metastatic digestive tract tumors 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 treatments 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 (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

Exclusion Criteria:

1. Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks prior to the first dose or within 5 half-lives;
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. Patients with 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 metastases;
11. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;
12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
13. Cumulative dose of anthracyclines \>360 mg/m² in previous (neo)adjuvant anthracycline therapy;
14. Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
15. History of interstitial lung disease (ILD) requiring steroid treatment, or current ILD;
16. Active infection requiring systemic treatment within 4 weeks prior to the first investigational drug dose;
17. Pleural, abdominal, 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

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Gastrointestinal Tumors; Solid Tumors