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Recruiting Phase 2

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

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About this study

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.

Condition
Breast Cancer
Tested
BL-B01D1, SI-B003
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.

Who can join

Age
18 to 75 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 21

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Eligible sex: Female
  • Study condition: Breast Cancer
  • 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.
  • 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.

Exclusion 36

  • 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)
  • 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.

Where

1 site, 1 recruiting

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.