NCT06471205招募中2 期
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative 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
- •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;
- •Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;
- •Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;
- •A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;
- •Must have at least one place in accordance with RECIST v1.1 define measurable lesions;
- •No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
排除标准
- •ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
- •Palliative radiotherapy within 2 weeks before the first dose;
- •Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
- •Use of an immunomodulatory drug within 14 days before the first dose of study drug;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Active autoimmune and inflammatory diseases;
- •Receiving long-term systemic corticosteroid therapy, etc., before the first dose;
- •Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- •Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
- •Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD;
- •Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
- •6 months prior to screening needs treatment intervention unstable thrombotic events;
- •Patients with active central nervous system metastases;
- •Patients with massive or symptomatic effusions or poorly controlled effusions;
- •Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;
- •Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- •Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;
- •Participated in another clinical trial within 4 weeks before the first dose;
- •Patients with superior vena cava syndrome should not be rehydrated;
- •Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;
- •Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
- •Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
- •Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- •Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
- •Other circumstances considered by the investigator to be inappropriate for participation in the trial.
研究组 & 干预措施
BL-B01D1+PD-1 Monoclonal Antibody
Experimental
Participants receive BL-B01D1+PD-1 Monoclonal Antibody 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-B01D1 (Drug)
BL-B01D1+PD-1 Monoclonal Antibody
Experimental
Participants receive BL-B01D1+PD-1 Monoclonal Antibody 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: PD-1 Monoclonal Antibody (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
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-B01D1.
次要结局
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid TumorsSolid TumorNon-small Cell Lung CancerNasopharyngeal CarcinomaNCT06475300Sichuan Baili Pharmaceutical Co., Ltd.570
招募中
2 期
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung CancerNon-small Cell Lung CancerNCT06498986Sichuan Baili Pharmaceutical Co., Ltd.40
招募中
2 期
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid TumorsHead and Neck Squamous Cell CarcinomaNCT06437522Sichuan Baili Pharmaceutical Co., Ltd.46
招募中
2 期
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung CancerExtensive-stage Small-cell Lung CancerNCT06437509Sichuan Baili Pharmaceutical Co., Ltd.66
招募中
2 期
A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial CarcinomaUrothelial CarcinomaNCT06405425Sichuan Baili Pharmaceutical Co., Ltd.52