A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: BL-M07D1; Drug: DS-8201

Detailed Description

In this trial, the treatment group receives BL-M07D1, and the control group receives DS-8201.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Binghe Xu

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 agree to comply with the protocol requirements；
2. Female patients aged ≥18 years and ≤75 years at the time of signing the informed consent form；
3. Life expectancy ≥12 weeks；
4. Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；
5. Provide adequate and recent tumor tissue specimens for central laboratory testing of HER2, HR, and other biomarkers as required；
6. Meet the prior treatment requirements as specified in the protocol；
7. Have at least one measurable target lesion per RECIST v1.1 criteria；
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
9. Toxicities from prior antitumor therapy have recovered to ≤Grade 1 per NCI-CTCAE v6.0；
10. Adequate organ function as defined in the protocol；
11. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative; patients must not be breastfeeding. All enrolled patients (both male and female) must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after the last dose of study treatment.

Exclusion Criteria:

1. Received surgery, curative radiotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks prior to the first dose;
2. Intolerance to the control drug or presence of other contraindications to the control drug;
3. Prior treatment with anti-HER2 therapy;
4. Prior treatment with an ADC (antibody-drug conjugate) using a camptothecin derivative as the payload;
5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
6. Concurrent pulmonary disease resulting in severely impaired lung function;
7. History of ILD/interstitial lung disease requiring corticosteroid therapy, etc.;
8. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
9. Diagnosis of another primary malignancy within 5 years prior to the first dose;
10. Uncontrolled hypertension;
11. Active central nervous system (CNS) metastases;
12. History of severe allergic reactions to any excipient or component of the investigational drug;
13. History of autologous or allogeneic stem cell transplantation or organ transplantation;
14. Prior anthracycline treatment with a cumulative equivalent dose of doxorubicin > 360 mg/m²;
15. Positive for human immunodeficiency virus (HIV) antibody, active hepatitis B virus (HBV) infection, liver cirrhosis, or hepatitis C virus (HCV) infection;
16. Occurrence of severe infection within 4 weeks prior to the first dose of the investigational drug;
17. Presence of large-volume serous cavity effusion, or serous cavity effusion with significant symptoms;
18. Presence of lymphangitic carcinomatosis;
19. Receiving systemic corticosteroid therapy at a dose of > 10 mg/day prednisone or equivalent prior to randomization;
20. Presence of severe neurological or psychiatric disorders;
21. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
22. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
23. Planned vaccination or receipt of live vaccine within 28 days prior to the first dose;
24. Presence of other severe physical conditions, laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with the study results, or render the patient unsuitable for enrollment as judged by the investigator.

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; Participants receive BL-M07D1 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.
Active Comparator: DS-8201; Participants receive DS-8201 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: DS-8201; 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): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; trastuzumab deruxtecan
• Other Study ID Numbers: BL-M07D1-208

Drug and device information, study documents

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