A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

NCT ID: NCT06316531

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-05-31

Brief Summary

This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.

Conditions

HER2-positive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 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-M07D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Control group

Participants receive T-DM1 as intravenous infusion for the first cycle (3 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

T-DM1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

BL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

T-DM1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent and follow the requirements of the protocol;

2. No gender limit;

3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;

4. expected survival time ≥3 months;

5. Patients with histologically or cytologically confirmed, unresectable, locally advanced or metastatic HER2-positive breast cancer;

6. Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;

7. Must have at least one measurable target lesion that meets the RECIST v1.1 definition;

8. ECOG 0 or 1;

9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. Blood transfusion is not allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed;

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 performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 7 months after the end of treatment.

Exclusion Criteria

1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery, chemotherapy, immunotherapy, etc. Within 4 weeks before the first dose, received endocrine therapy, palliative radiotherapy, and anti-tumor therapy approved by NMPA within 2 weeks before the first dose;

2. Previous use of HER2-ADC in the metastatic background;

3. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;

4. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;

5. Complicated with pulmonary diseases leading to severe impairment of lung function;

6. History of ILD/interstitial pneumonia, current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia; According to CTCAE v5.0 was defined as ≥ grade 3 pulmonary disease and ≥ grade 2 radiation pneumonitis;

7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;

8. Other primary malignancies diagnosed within 5 years before the first dose;

9. Poorly controlled hypertension (systolic blood pressure &gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg);

10. Patients with active central nervous system metastases;

11. Patients with a history of allergy to recombinant humanized antibody or to any of the excipents of BL-M07D1;

12. Patients with known hypersensitivity or delayed hypersensitivity to certain components of T-DM1 or similar drugs, or known contraindications to T-DM1;

13. History of autologous or allogeneic stem cell transplantation or organ transplantation;

14. Anthracycline-equivalent cumulative dose of adriamycin > 360 mg/m2;

15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;

16. Serious infection within 4 weeks before the first dose of study drug; There was active pulmonary inflammation at the time of screening;

17. Patients with massive or symptomatic effusions or poorly controlled effusions;

18. Receiving active antiinflammatory drugs or any form of immunosuppressive therapy before randomization;

19. A history of severe neurological or psychiatric illness;

20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;

21. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;

22. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;

23. Patients who were deemed by the investigator to be ineligible for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Principal Investigators

Erwei Song

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Herui Yao

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

BL-M07D1-301

Identifier Type: -

Identifier Source: org_study_id