A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

NCT ID: NCT06445400

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2026-06-30

Brief Summary

This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Conditions

HER2-positive Breast Cancer

Study Design

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

Study Groups

Study treatment

Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

Group Type: EXPERIMENTAL

BL-M07D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pertuzumab

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Docetaxel

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

Pertuzumab

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Docetaxel

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age ≥18 years old and ≤75 years old;

4. Expected survival time for 3 months or more;

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

6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. Physical condition score ECOG 0 or 1 ;

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

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

11. No blood transfusion, no colony-stimulating factor, and no albumin are allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;

12. Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the end of the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria

1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery within 4 weeks before the first dose, and received endocrine therapy within 2 weeks before the first dose;

2. Patients with locally advanced or metastatic disease who have received previous systemic therapy;

3. Had received prior ADC drug therapy with camptothecin derivative as toxin;

4. Screening within the first half of the serious heart, cerebrovascular disease;

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

6. A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected ILD;

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;

10. Patients with active central nervous system metastases;

11. Need treatment intervention of unstable thrombotic events, except infusion related thrombosis;

12. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;

13. Had received more than the following cumulative doses of anthracyclines;

14. Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;

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

16. Severe systemic infection within 4 weeks before screening;

17. Active autoimmune and inflammatory diseases;

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

19. Previous history of allogeneic stem cell, bone marrow or organ transplantation;

20. A history of severe neurological or psychiatric illness;

21. Pregnancy or lactation women;

22. Patients who were deemed by the investigator to be ineligible for participation in 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

Herui Yao

Role: PRINCIPAL_INVESTIGATOR

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

Qiang Liu

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

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Herui Yao

Role: primary

Other Identifiers

BL-M07D1-205

Identifier Type: -

Identifier Source: org_study_id