A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Recommended Phase II Dose (RP2D)
研究概览
简要总结
This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Gender is not limited;
- •Age ≥18 years old and ≤75 years old;
- •Expected survival time for 3 months or more;
- •Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic HER2-positive breast cancer;
- •Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •Physical condition score ECOG 0 or 1 ;
- •The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •No blood transfusion, no colony-stimulating factor, and no albumin are allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
- •Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
- •Urinary protein ≤2+ or ≤1000mg/24h;
- •Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the end of the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.
排除标准
- •Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery within 4 weeks before the first dose, and received endocrine therapy within 2 weeks before the first dose;
- •Patients with locally advanced or metastatic disease who have received previous systemic therapy;
- •Had received prior ADC drug therapy with camptothecin derivative as toxin;
- •Screening within the first half of the serious heart, cerebrovascular disease;
- •Complicated with pulmonary diseases leading to severe impairment of lung function;
- •A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected ILD;
- •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;
- •Need treatment intervention of unstable thrombotic events, except infusion related thrombosis;
- •Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
- •Had received more than the following cumulative doses of anthracyclines;
- •Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
- •Patients with massive or symptomatic effusions or poorly controlled effusions;
- •Severe systemic infection within 4 weeks before screening;
- •Active autoimmune and inflammatory diseases;
- •Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
- •Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- •A history of severe neurological or psychiatric illness;
- •Pregnancy or lactation women;
- •Patients who were deemed by the investigator to be ineligible for participation in the study.
研究组 & 干预措施
Study treatment
Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
干预措施: BL-M07D1 (Drug)
Study treatment
Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
干预措施: Docetaxel (Drug)
Study treatment
Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Recommended Phase II Dose (RP2D)
时间窗: Up to approximately 24 months
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 of BL-M07D1.
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
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.
次要结局
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Progression-free Survival (PFS)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)