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HER2-positive Breast CancerPhase 3NCT06316531

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

A Phase 3 study testing BL-M07D1 and T-DM1 in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
BL-M07D1 and T-DM1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
1 siteChina
Study dates
8 May 2024to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent and follow the requirements of the protocol;
  • No gender limit;
  • Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
  • expected survival time ≥3 months;
  • Patients with histologically or cytologically confirmed, unresectable, locally advanced or metastatic HER2-positive breast cancer;
  • Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
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  • 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;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • Blood transfusion is not allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed;
  • Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT)≤1.5×ULN;
  • Urine protein ≤2+ or < 1000mg/24h;
  • 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) were advised to use adequate barrier contraception throughout the treatment cycle and for 7 months after the end of treatment.

Who cannot join

  • Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery, chemotherapy, immunotherapy, etc. Within 4 weeks before the first dose, received endocrine therapy, palliative radiotherapy, and anti-tumor therapy approved by NMPA within 2 weeks before the first dose;
  • Previous use of HER2-ADC in the metastatic background;
  • Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
  • The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
  • Complicated with pulmonary diseases leading to severe impairment of lung function;
  • History of ILD/interstitial pneumonia, current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia; According to CTCAE v5.0 was defined as ≥ grade 3 pulmonary disease and ≥ grade 2 radiation pneumonitis;
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  • 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 (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
  • Patients with active central nervous system metastases;
  • Patients with a history of allergy to recombinant humanized antibody or to any of the excipents of BL-M07D1;
  • Patients with known hypersensitivity or delayed hypersensitivity to certain components of T-DM1 or similar drugs, or known contraindications to T-DM1;
  • 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;
  • Serious infection within 4 weeks before the first dose of study drug; There was active pulmonary inflammation at the time of screening;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Receiving active antiinflammatory drugs or any form of immunosuppressive therapy before randomization;
  • A history of severe neurological or psychiatric illness;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
  • Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
  • Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
  • Patients who were deemed by the investigator to be ineligible for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.

Being tested
BL-M07D1, T-DM1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M07D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • T-DM1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06316531
Study groupRoleWhat they receive
Experimental GroupExperimentalParticipants 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.
Receives: Drug: BL-M07D1
Control groupExperimentalParticipants receive T-DM1 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.
Receives: Drug: T-DM1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BIRC 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.

    Measured: Up to approximately 24 months

Secondary outcomes (6)

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

    Measured: Up to approximately 24 months

  2. 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).

    Measured: Up to approximately 24 months

  3. 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.

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

  5. 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.

    Measured: Up to approximately 24 months

  6. Anti-drug antibody (ADA)

    Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start8 May 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316531
Sponsor's protocol ID
BL-M07D1-301
Status last verified
Jul 2026
First submitted
12 Mar 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-M07D1 and T-DM1 in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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