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

NCT07678957 | Recruiting Phase 2

• 1 other identifier: BL-M07D1-208
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall survival (OS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Clinical Benefit Rate(CBR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

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

DS-8201

ACTIVE COMPARATOR

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

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

DS-8201 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

DS-8201

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and agree to comply with the protocol requirements；
• Female patients aged ≥18 years and ≤75 years at the time of signing the informed consent form；
• Life expectancy ≥12 weeks；
• Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；
• Provide adequate and recent tumor tissue specimens for central laboratory testing of HER2, HR, and other biomarkers as required；
• Meet the prior treatment requirements as specified in the protocol；
• Have at least one measurable target lesion per RECIST v1.1 criteria；
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
• Toxicities from prior antitumor therapy have recovered to ≤Grade 1 per NCI-CTCAE v6.0；
• Adequate organ function as defined in the protocol；
• 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.

You may not qualify if:

• Received surgery, curative radiotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks prior to the first dose;
• Intolerance to the control drug or presence of other contraindications to the control drug;
• Prior treatment with anti-HER2 therapy;
• Prior treatment with an ADC (antibody-drug conjugate) using a camptothecin derivative as the payload;
• History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
• Concurrent pulmonary disease resulting in severely impaired lung function;
• History of ILD/interstitial lung disease requiring corticosteroid therapy, etc.;
• QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Diagnosis of another primary malignancy within 5 years prior to the first dose;
• Uncontrolled hypertension;
• Active central nervous system (CNS) metastases;
• History of severe allergic reactions to any excipient or component of the investigational drug;
• History of autologous or allogeneic stem cell transplantation or organ transplantation;
• Prior anthracycline treatment with a cumulative equivalent dose of doxorubicin \> 360 mg/m²;
• Positive for human immunodeficiency virus (HIV) antibody, active hepatitis B virus (HBV) infection, liver cirrhosis, or hepatitis C virus (HCV) infection;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

CN (1)