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

NCT06042894 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-SI-B003-201-04
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

HER-2 negative

Outcome Measures

Primary Outcomes (2)

• 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.

  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 .

  Up to approximately 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease control rate (DCR)

  Up to approximately 24 months

• Duration of response (DOR)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

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.

Drug: BL-B01D1; Drug: SI-B003

Interventions

BL-B01D1 DRUG

BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + SI-B003

SI-B003 DRUG

SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.

BL-B01D1 + SI-B003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• 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.
• 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.
• 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.

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jiong Wu, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian Zhang, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CN (1)