A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

NCT06957886 | Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-304
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 2

Brief Summary

This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.

Conditions

HER2-low 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 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.

Drug: BL-M07D1

investigator's choice of chemotherapy

ACTIVE COMPARATOR

Participants receive Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel for the first cycle. 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: Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel DRUG

Oral administration of Capecitabine. Administration by intravenous infusion of Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel.

investigator's choice of chemotherapy

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 and follow the requirements of the protocol;
• Women aged ≥18 years and ≤75 years at the time of written informed consent;
• Expected survival time ≥12 weeks;
• Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;
• Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
• Meet the treatment requirements in the plan;
• Must have at least one measurable target lesion that meets the RECIST v1.1 definition;
• ECOG 0 or 1;
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• Organ function level must meet the requirements;
• 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) should use adequate, highly effective contraception for the entire treatment cycle and for 7 months after completion of treatment.

You may not qualify if:

• Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks before the first dose;
• Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control group or other contraindications;
• Previous treatment with anti-HER2 drugs;
• Prior ADC drug therapy with camptothecin derivative as toxin;
• The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
• Severe impairment of lung function due to concurrent pulmonary diseases;
• History of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia or suspected ILD/interstitial pneumonia;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Other primary malignancies diagnosed within 5 years before the first dose;
• Poorly controlled hypertension;
• Patients with active central nervous system metastases;
• Patients with a history of severe allergy to any excipients or components of the study drug;
• History of autologous or allogeneic stem cell transplantation or organ transplantation;
• Anthracycline-equivalent cumulative dose of adriamycin \> 360 mg/m2;
• Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;

Sponsors & Collaborators

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

Study Sites (2)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

MeSH Terms

Interventions

Capecitabine; eribulin; Gemcitabine; Paclitaxel

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (2)