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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
+8615013238943
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 58
Treatments
Experimental: BL-B01D1 + SI-B003
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.
Sponsors
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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