NCT06957886招募中3 期
A Randomized, Controlled Phase III Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 566
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low 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 and follow the requirements of the protocol;
- •Women aged ≥18 years and ≤75 years at the time of written informed consent;
- •Expected survival time ≥12 weeks;
- •Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;
- •Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
- •Meet the treatment requirements in the plan;
- •Must have at least one measurable target lesion that meets the RECIST v1.1 definition;
- •ECOG 0 or 1;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •Organ function level must meet the requirements;
- •For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) should use adequate, highly effective contraception for the entire treatment cycle and for 7 months after completion of treatment.
排除标准
- •Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks before the first dose;
- •Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control group or other contraindications;
- •Previous treatment with anti-HER2 drugs;
- •Prior ADC drug therapy with camptothecin derivative as toxin;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- •Severe impairment of lung function due to concurrent pulmonary diseases;
- •History of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia or suspected ILD/interstitial pneumonia;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Other primary malignancies diagnosed within 5 years before the first dose;
- •Poorly controlled hypertension;
- •Patients with active central nervous system metastases;
- •Patients with a history of severe allergy to any excipients or components of the study drug;
- •History of autologous or allogeneic stem cell transplantation or organ transplantation;
- •Anthracycline-equivalent cumulative dose of adriamycin > 360 mg/m2;
- •Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
- •Serious infection within 4 weeks before the first dose of study drug; Severe infection requiring antibiotic, antiviral or antifungal control at screening;
- •Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;
- •Carcinomatous lymphangitis;
- •Was receiving > before randomization; 10mg/d prednisone systemic corticosteroids or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;
- •The presence of a severe neurological or mental illness;
- •Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- •Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
- •Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
- •Patients with other serious physical or laboratory abnormalities or poor compliance that may increase the risk of participating in the study or interfere with the results of the study, and patients who are considered by the investigators to be unsuitable for participating in the study.
研究组 & 干预措施
BL-M07D1
Experimental
Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-M07D1 (Drug)
investigator's choice of chemotherapy
Active Comparator
Participants receive Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel for the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel (Drug)
结局指标
主要结局
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
- Overall survival (OS)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Clinical Benefit Rate (CBR)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
3 期
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)Non-small Cell Lung CancerNCT06838273Sichuan Baili Pharmaceutical Co., Ltd.720
进行中（未招募）
3 期
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer(PANKU-Breast02)Triple-Negative Breast CancerNCT06382142Sichuan Baili Pharmaceutical Co., Ltd.418
进行中（未招募）
3 期
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)Small Cell Lung CancerNCT06500026Sichuan Baili Pharmaceutical Co., Ltd.722
进行中（未招募）
3 期
A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02)Non-small Cell Lung CancerNCT06382129Sichuan Baili Pharmaceutical Co., Ltd.698
进行中（未招募）
3 期
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)HR+HER2- Breast CancerNCT06343948Sichuan Baili Pharmaceutical Co., Ltd.383