A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: BL-M07D1; Drug: Docetaxel; Drug: Pertuzumab; Drug: Trastuzumab

Detailed Description

In this trial, the treatment group receives BL-M07D1 and pertuzumab, while the control group receives trastuzumab, pertuzumab, and docetaxel.

• Study Type: Interventional
• Enrollment (Estimated): 596
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Principal Investigator: Herui Yao
      • Contact: Herui Yao
      • Principal Investigator: Qiang Liu
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
      • Contact: Ting Luo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;
3. Expected survival time ≥12 weeks;
4. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;
5. Clear hormone receptor (HR) status;
6. Agree to provide eligible tumor tissue specimens;
7. Have at least one measurable target lesion as defined by RECIST v1.1;
8. ECOG performance status score of 0 or 1;
9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. Organ function levels must meet the requirements;
11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.

Exclusion Criteria:

1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.
2. Previously received ADC drug therapy with camptothecin derivatives as toxins.
3. History of severe cardiovascular or cerebrovascular disease within six months before screening.
4. Concomitant pulmonary disease resulting in severely impaired lung function.
5. History of interstitial lung disease (ILD)/interstitial pneumonia requiring corticosteroid therapy, etc.
6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.
7. Diagnosed with another primary malignancy within 5 years before the first dose.
8. Newly developed deep vein thrombosis within 14 days before screening.
9. Hypertension poorly controlled by antihypertensive medications.
10. Patients with active central nervous system metastases.
11. History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.
12. History of autologous or allogeneic stem cell transplantation or organ transplantation.
13. Previously received anthracycline therapy exceeding the prescribed dose limit.
14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.
15. Severe infection within 4 weeks prior to the first use of the study drug, etc.
16. Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.
17. Receiving systemic corticosteroid therapy >10 mg/day prednisone or equivalent prior to randomization, etc.
18. Presence of severe neurological or psychiatric disorders.
19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.
20. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.
21. Subjects planning to receive or having received live vaccines within 28 days before the first dose.
22. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study in the investigator's opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-M07D1 + Pertuzumab; Participants receive BL-M07D1 + Pertuzumab in 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.	Drug: BL-M07D1; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Pertuzumab; Administration by intravenous infusion for a cycle of 3 weeks.
Active Comparator: Docetaxel + Trastuzumab + Pertuzumab; Participants receive Docetaxel + Trastuzumab + Pertuzumab in 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.	Drug: Docetaxel; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Pertuzumab; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Trastuzumab; Administration by intravenous infusion for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.	Up to approximately 24 months
Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).	Up to approximately 24 months
Disease Control Rate (DCR)	Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.	Up to approximately 24 months
Duration of Response (DOR)	Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.	Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.	Up to approximately 24 months
Anti-drug antibody (ADA)	Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.	Up to approximately 24 months
Clinical Benefit Rate(CBR)	Clinical Benefit Rate (CBR): The proportion of subjects who were randomized and received at least one dose of the study drug, and whose best overall response (BOR) according to RECIST v1.1 criteria was complete response (CR), partial response (PR), or stable disease (SD) lasting no less than 24 weeks.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Trastuzumab; pertuzumab
• Other Study ID Numbers: BL-M07D1-307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No