NCT07279428 A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
| NCT ID | NCT07279428 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Gastrointestinal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2026-01-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an open, multicenter, non-randomized phase I clinical trial 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07279428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07279428 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07279428 currently recruiting?
Yes, NCT07279428 is actively recruiting participants. Contact the research team at xiaosa@baili-pharm.com for enrollment information.
Where is the NCT07279428 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07279428 clinical trial?
NCT07279428 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. The trial plans to enroll 33 participants.