A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

NCT ID: NCT07279428

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

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.

Detailed Description

The study is divided into two phases: a dose escalation phase (Phase Ia) and a cohort expansion phase (Phase Ib).

Conditions

Gastrointestinal Tumors; Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BL-M24D1

Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-M24D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

Interventions

BL-M24D1

Administration by intravenous infusion for a cycle of 2 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Lin Shen

Role: primary

Other Identifiers

BL-M24D1-102

Identifier Type: -

Identifier Source: org_study_id