NCT06994195招募中3 期
A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 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, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •Age: ≥18 years old;
- •Expected survival time ≥3 months;
- •Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- •Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;
- •Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;
- •For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;
- •Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •ECOG performance status score of 0 or 1;
- •Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- •Organ function levels must meet the requirements;
- •Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- •For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
排除标准
- •Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;
- •Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;
- •Front line received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3;
- •History of severe heart disease and cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Diagnosed with active malignancy within 3 years before randomization;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •Patients with poor glycemic control;
- •Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD;
- •Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- •Patients with active central nervous system metastases;
- •Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
- •Patients with massive or symptomatic effusions or poorly controlled effusions;
- •Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
- •Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
- •Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- •Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
- •Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
- •Had a history of autologous or allogeneic stem cell transplantation;
- •Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
- •A history of severe neurological or psychiatric illness;
- •Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
- •Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;
- •Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.
研究组 & 干预措施
Investigator's choice of chemotherapy
Active Comparator
Participants receive Liposomal doxorubicin, Paclitaxel or Topotecan in the first cycle (4 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: Liposomal doxorubicin, Paclitaxel or Topotecan (Drug)
BL-B01D1
Experimental
Participants receive BL-B01D1 in 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)
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 BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Overall survival (OS)
时间窗: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Progression-free survival (PFS)
时间窗: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
次要结局
- 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)
- RR (Response Rate)(Up to approximately 24 months)
- CA-125 Response Rate(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(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)
- RR (Response Rate)(Up to approximately 24 months)
- CA-125 Response Rate(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Time to Response (TTR)(Up to approximately 24 months)
研究者
研究点 (1)
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