Breast CancerPhase 2NCT07678957
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
A Phase 2 study testing BL-M07D1 and DS-8201 in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BL-M07D1 and DS-8201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to Dec 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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.
Who cannot join
- 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;
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- 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;
- Occurrence of severe infection within 4 weeks prior to the first dose of the investigational drug;
- Presence of large-volume serous cavity effusion, or serous cavity effusion with significant symptoms;
- Presence of lymphangitic carcinomatosis;
- Receiving systemic corticosteroid therapy at a dose of > 10 mg/day prednisone or equivalent prior to randomization;
- Presence of severe neurological or psychiatric disorders;
- Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
- Planned vaccination or receipt of live vaccine within 28 days prior to the first dose;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Binghe Xu
About this study
Official title: 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.
Read the detailed description
In this trial, the treatment group receives BL-M07D1, and the control group receives DS-8201.
- Conditions
- Breast Cancer
- Being tested
- BL-M07D1, DS-8201
- Medical subject headings
- Breast Neoplasms
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.
DS-8201Drug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: DS-8201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 24 months
Secondary outcomes (7)
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
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
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
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 24 months
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.
- First posted1 Jul 2026
- Study start31 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678957
- Sponsor's protocol ID
- BL-M07D1-208
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07678957
- Acronym / sponsor ID
- BL-M07D1-208
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this trial, the treatment group receives BL-M07D1, and the control group receives DS-8201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-M07D1 | Experimental | Drug: BL-M07D1Participants 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. |
| DS-8201 | Active comparator | Drug: DS-8201Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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；
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M07D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1 |
| DS-8201Administration by intravenous infusion for a cycle of 3 weeks. | Drug | DS-8201 |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
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.
7 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Clinical Benefit Rate(CBR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-M07D1 and DS-8201 in people with 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 11 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. 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?
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 14 Sep 2026.