NCT06787664进行中（未招募）2 期
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Locally Advanced or Metastatic Chordoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open-label, multicenter phase II study to evaluate the safety, efficacy and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with locally advanced or metastatic chordoma.
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;
- •Locally advanced (unresectable) or metastatic chordoma confirmed by histopathology;
- •The expected survival time as judged by the investigator was ≥3 months;
- •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%;
- •Organ function level must meet the requirements;
- •Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
- •Urine protein ≤2+ or < 1000mg/24h;
- •For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a 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
- •Chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, and palliative radiotherapy within 2 weeks;
- •A history of central nervous system hemorrhage/infarction requiring treatment within 6 months before enrollment;
- •History of severe heart disease and cerebrovascular disease;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- •Active autoimmune and inflammatory diseases;
- •Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- •Poorly controlled hypertension (systolic blood pressure after adequate medical therapy > 150 mmHg or diastolic blood pressure > 100 mmHg);
- •Poor glycemic control;
- •Patients with a previous history of ILD requiring hormone therapy, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such a condition during screening;
- •Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- •Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1;
- •Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- •Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- •Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug;
- •Imaging examination indicated that the tumor had invaded or enveloped the large blood vessels of the chest, neck, abdomen, ilium, and pharynx, except that the investigator thought that it would not affect the patient's medication;
- •With a history of psychotropic drug abuse and inability to quit or a history of severe neurological or psychiatric illness;
- •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;
- •Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose;
- •Had participated in another clinical trial within 4 weeks before the first dose;
- •Other circumstances that the investigator deemed inappropriate for participation in the trial.
研究组 & 干预措施
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
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
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Duration of response (DOR)(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)
- Ctrough(Up to approximately 24 months)
- ADA (anti-drug antibody)(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 in Patients With Recurrent GlioblastomaRecurrent GlioblastomaNCT06598787Sichuan Baili Pharmaceutical Co., Ltd.20
进行中（未招募）
2 期
A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction AdenocarcinomaHER2-positive Gastric or Gastroesophageal Junction AdenocarcinomaNCT06423885Sichuan Baili Pharmaceutical Co., Ltd.64
进行中（未招募）
2 期
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell LymphomaLymphomaNCT04980222Hoffmann-La Roche46
已完成
2 期
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic LeukemiaB-Cell Chronic Lymphocytic Leukemia (B-CLL)NCT00328198Genzyme, a Sanofi Company86
进行中（未招募）
2 期
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSLSecondary Central Nervous System LymphomaPCNSLNCT04438044Beijing InnoCare Pharma Tech Co., Ltd.61