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HER2-positive Breast CancerPhase 2NCT06445400

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

A Phase 2 study testing BL-M07D1, Pertuzumab and Docetaxel 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 phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. 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, Pertuzumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteChina
Study dates
19 Jun 2024to Dec 2026
Phase
Phase 2
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

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Gender is not limited;
  • Age ≥18 years old and ≤75 years old;
  • Expected survival time for 3 months or more;
  • Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic HER2-positive breast cancer;
  • Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
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  • At least one measurable lesion meeting the RECIST v1.1 definition was required;
  • Physical condition score ECOG 0 or 1 ;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • No blood transfusion, no colony-stimulating factor, and no albumin are allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
  • Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
  • Urinary protein ≤2+ or ≤1000mg/24h;
  • Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the end of the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Who cannot join

  • Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery within 4 weeks before the first dose, and received endocrine therapy within 2 weeks before the first dose;
  • Patients with locally advanced or metastatic disease who have received previous systemic therapy;
  • Had received prior ADC drug therapy with camptothecin derivative as toxin;
  • Screening within the first half of the serious heart, cerebrovascular disease;
  • Complicated with pulmonary diseases leading to severe impairment of lung function;
  • A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected ILD;
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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;
  • Patients with active central nervous system metastases;
  • Need treatment intervention of unstable thrombotic events, except infusion related thrombosis;
  • Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
  • Had received more than the following cumulative doses of anthracyclines;
  • Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Severe systemic infection within 4 weeks before screening;
  • Active autoimmune and inflammatory diseases;
  • Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
  • Previous history of allogeneic stem cell, bone marrow or organ transplantation;
  • A history of severe neurological or psychiatric illness;
  • Pregnancy or lactation women;
  • Patients who were deemed by the investigator to be ineligible for participation in 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 Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Being tested
BL-M07D1, Pertuzumab, Docetaxel

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.

  • PertuzumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • DocetaxelDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06445400
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Receives: Drug: BL-M07D1; Drug: Pertuzumab; Drug: Docetaxel

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

  2. Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  4. 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

Timeline

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

  1. First posted6 Jun 2024
  2. Study start19 Jun 2024
  3. Primary completion21 Jul 2025
  4. Study completionDec 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06445400
Sponsor's protocol ID
BL-M07D1-205
Status last verified
Jul 2026
First submitted
31 May 2024
Last updated
29 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 2 study testing BL-M07D1, Pertuzumab and Docetaxel 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 22 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 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. 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 NCT06445400.

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 29 Jul 2026.

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