Breast CancerPhase 2NCT06042894

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

A Phase 2 study testing BL-B01D1 and SI-B003 in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative 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-B01D1 and SI-B003
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteChina
Study dates: 12 Dec 2023to Dec 2027
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 and follow the requirements of the protocol.
Age: ≥18 years old and ≤75 years old.
Expected survival time ≥3 months.
ECOG 0 or 1.
Pathologically and/or cytologically confirmed patients who have failed standard treatment, or have no access to standard treatment Patients with unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer after posterior line.
Agree to provide archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years. 10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples if the subject is unable to provide them for 2 years tumor tissue samples from within, can be communicated with the sponsor if other inclusion criteria are met, enrollment was permitted after investigator assessment.

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Must have at least one measurable lesion according to RECIST v1.1 definition; So let's say that we've done this before radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy measurable lesions were entered.
Blood transfusions, the use of any cell growth factors, and/or blood transfusions were not allowed within 14 days before screening in the presence of a platelet drug, the organ function level must meet the following criteria:
Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5× 10 9 /L; Platelet count (PLT) ≥ 90× 10 9 /L;
Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (According to Cockcroft and Gault formula);
Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) was ≤2.5 ULN in all patients, and AST and ALT were ≤ in patients with liver metastasis 5.0 ULN;
Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;
no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;
proteinuria ≤2+ or ≤1000mg/24h.
Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (investigator review) concerns about asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, hyperglycemia, etc., and investigators toxicity without safety risk was judged, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L except).
A pregnancy test should be performed within 7 days of starting treatment for premenopausal women who are likely to have children clear or urine pregnancy tests must be negative and must be non-lactating; All enrolled patients should be in the entire treatment week adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment.

Who cannot join

ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins.
Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy; Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose.
Use of immunomodulatory drugs within 14 days before the first use of the study drug: including but not limited to thymosin, interleukin-2, interferon, etc.
Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts); Inhaled or topical administration of hormones, or received physiology for adrenal insufficiency alternative doses of hormone therapy were excluded.
Patients with grade ≥3 irAE or grade ≥2 immune-related myocarditis who had received immunotherapy were excluded.
A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:

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severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias or grade III atria requiring clinical intervention Ventricular block;
prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in women);
myocardial infarction, unstable angina, cardiac angioplasty, or within 6 months before the first dose Stent implantation, coronary artery/peripheral artery bypass grafting, New York Heart Association Defined class III or IV congestive heart failure, cerebrovascular accident, or transient ischemic attack.
Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, silver requiring systemic treatment dandruptitis, rheumatoid arthritis, inflammatory bowel disease and hashimoto's thyroiditis, except type I diabetes, hypothyroidism that can be controlled only by replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, silver) Dandruff).
Other malignancies that progressed or required treatment within 3 years before the first dose, such as the following external: radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical carcinoma in situ.
History or current history of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid therapy patients with ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be excluded by imaging at the time of screening.
Prior to starting the study treatment, there are:
Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)
Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
History of hypertensive crisis or hypertensive encephalopathy.
Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening thrombotic events such as plug; Infusion-related thrombosis was excluded.
Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). Patients who had received treatment for brain metastases (radiotherapy or surgery; Patients with stable brain metastases who had stopped radiotherapy or surgery 28 days before the first dose were eligible. Patients with cancerous meningitis (meningeal metastasis) were excluded even if they were treated and judged to be stable. Stability is defined as meeting the following four criteria:
seizure-free status for > 12 weeks with or without antiepileptic medication;
no need for corticosteroids;
stable on two consecutive MRI scans (at least 4 weeks apart);
stable and asymptomatic for more than one month after treatment.
Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage.
Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or any excipients of BL-B01D1 sensitive patients.
Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit).
Positive hepatitis B surface antigen (HBsAg) and HBV DNA> 500IU/ml or 2000 copies /ml patients with HBV infection should receive antiviral treatment according to local treatment guidelines and be willing to participate in the study all patients received antiviral therapy during the whole period.
Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).
Persons with a history of psychotropic drug abuse and inability to quit or mental disorders.
Any other circumstances that the investigator deemed inappropriate for participation in the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jiong Wu
Jian Zhang
Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

Conditions: Breast Cancer
Being tested: BL-B01D1, SI-B003
Keywords: HER-2 negative
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-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
SI-B003Drug
SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.

Study groups in NCT06042894
Study group	Role	What they receive
BL-B01D1 + SI-B003	Experimental	Participants receive SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. Receives: Drug: BL-B01D1; Drug: SI-B003

What is being measured

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

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
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 .
Measured: Up to approximately 24 months

Secondary outcomes (4)

Progression-free survival (PFS)
The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
Measured: Up to approximately 24 months
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
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
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
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.

12 Dec 2023Dec 2027

First posted21 Sep 2023
Study start12 Dec 2023
Primary completionDec 2026 (estimated)
Study completionDec 2027 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06042894
Sponsor's protocol ID: BL-B01D1-SI-B003-201-04
Status last verified: Sep 2025
First submitted: 12 Sep 2023
Last updated: 26 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Sa Xiao, PHD

+8615013238943

xiaosa@baili-pharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT06042894
Acronym / sponsor ID: BL-B01D1-SI-B003-201-04
Conditions: Breast Cancer
Keywords: HER-2 negative
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 58 participants (estimated)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Dec 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 21 Sep 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BL-B01D1 + SI-B003	Experimental	Drug: BL-B01D1, Drug: SI-B003Participants receive SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Administration will be discontinued because of disease progression or intolerable toxicity or for 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 (16 listed)

Voluntarily sign the informed consent and follow the requirements of the protocol.
Age: ≥18 years old and ≤75 years old.
Expected survival time ≥3 months.
ECOG 0 or 1.
Pathologically and/or cytologically confirmed patients who have failed standard treatment, or have no access to standard treatment Patients with unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer after posterior line.

Key exclusion criteria (31 listed)

ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins.
Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy; Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose.
Use of immunomodulatory drugs within 14 days before the first use of the study drug: including but not limited to thymosin, interleukin-2, interferon, etc.
Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts); Inhaled or topical administration of hormones, or received physiology for adrenal insufficiency alternative doses of hormone therapy were excluded.
Patients with grade ≥3 irAE or grade ≥2 immune-related myocarditis who had received immunotherapy were excluded.

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-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.	Drug	BL-B01D1 + SI-B003
SI-B003SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.	Drug	BL-B01D1 + SI-B003

Primary outcome

Objective response rate (ORR)
Time frame: Up to approximately 24 months
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.
Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
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 .

4 secondary outcomes

Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Duration of response (DOR)
Time frame: Up to approximately 24 months
Treatment-Emergent Adverse Event (TEAE)
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 26 Sep 2025.

Related trials for Breast Cancer

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

Jiong Wu, PHD principal investigator

Fudan University

Jian Zhang, PHD principal investigator

Fudan University

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-B01D1 and SI-B003 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 16 inclusion and 31 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 26 Sep 2025. 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 (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. 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 NCT06042894.

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 26 Sep 2025.