NCT07729956尚未招募3 期
A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- BICR-assessed Progression-free Survival (PFS)
研究概览
简要总结
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
- •Female patients aged 18 to 75 years;
- •Expected survival time ≥ 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
- •Confirmed PD-L1 expression positivity by central laboratory testing;
- •No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
- •Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
- •Organ function levels must meet the protocol-specified requirements;
- •Urine protein ≤ 1+ or < 1000 mg/24 h;
- •For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.
排除标准
- •Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
- •Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
- •Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
- •Use of immunomodulators within 14 days before the first study drug dose;
- •History of severe cardiac or cerebrovascular disease;
- •Receiving chronic systemic corticosteroids at >10 mg/day prednisone before the first dose;
- •Active autoimmune or inflammatory disease;
- •Any thrombotic event within 6 months before randomization;
- •Prolonged QTc, complete left bundle branch block, or similar;
- •Active malignancy diagnosed within 3 years before randomization;
- •Hypertension uncontrolled by two antihypertensives;
- •Poorly controlled diabetes/hyperglycemia;
- •History of steroid-treated ILD/interstitial pneumonitis;
- •Concurrent lung disease causing clinically significant respiratory impairment;
- •Active CNS metastases;
- •Severe infection within 4 weeks before randomization;
- •Massive or symptomatic serosal effusion;
- •Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;
- •Clinically significant bleeding or bleeding tendency within 4 weeks before consent;
- •Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;
- •Allergy or contraindication to the study drug;
- •History of autologous/allogeneic stem cell transplantation;
- •HIV antibody positive, active HBV, or active HCV;
- •History of severe neurological or psychiatric illness;
- •Received or planning to receive live vaccine within 28 days before randomization;
- •Other conditions rendering the patient unsuitable per investigator's judgment.
结局指标
主要结局
BICR-assessed Progression-free Survival (PFS)
时间窗: 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.
次要结局
- CL (Clearance)(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Overall Survival (OS)(Up to approximately 24 months)
- Investigator-assessed Progression-free Survival (PFS)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Time to Response (TTR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- T1/2(Up to approximately 24 months)
- AUC0-t(Up to approximately 24 months)
- Anti-drug Antibody (ADA)(Up to approximately 24 months)
- Neutralizing Antibody(NAb)(Up to approximately 24 months)
研究者
研究点 (1)
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