NCT07818486尚未招募1 期
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma and Other Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recommended Phase II Dose (RP2D)
研究概览
简要总结
This Phase Ib/II study is a clinical trial to evaluate the efficacy and safety of BL-M08D1 for Injection in patients with recurrent or metastatic nasopharyngeal carcinoma and other solid tumors.
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 form and agree to comply with the protocol requirements;
- •No gender restriction;
- •Age: ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Recurrent or metastatic nasopharyngeal carcinoma and other solid tumors;
- •Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 3 years;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;
- •Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- •Organ function levels must meet the required criteria;
- •Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
- •Urine protein ≤1+ or ≤1000 mg/24h;
- •For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative, and they must be non-lactating; all enrolled patients (both male and female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;
- •The trial participant must be capable of and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.
排除标准
- •Use of chemotherapy, biotherapy, immunotherapy, or other systemic anti-cancer therapies within 4 weeks or 5 half-lives prior to the first dose;
- •History of severe cardiac or cerebrovascular disease;
- •Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
- •Active autoimmune diseases and inflammatory diseases;
- •Diagnosis of another primary malignancy within 5 years prior to the first dose;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
- •Hypertension inadequately controlled by antihypertensive medications;
- •Poorly controlled blood glucose (diabetes);
- •History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;
- •Severely impaired respiratory function;
- •Active central nervous system (CNS) metastases;
- •History of, or concurrent, central nervous system disorders;
- •History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of BL-M08D1;
- •Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- •Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;
- •Pleural, peritoneal, or pericardial effusion requiring drainage and/or associated with symptoms within 4 weeks prior to the first dose of study drug;
- •Imaging findings indicating that the tumor has invaded or encased major blood vessels (e.g., abdominal or thoracic vessels), the pericardium, or the heart;
- •Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
- •Pregnant or breastfeeding women;
- •Other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in this clinical trial.
研究组 & 干预措施
BL-M08D1
Experimental
Participants receive BL-M08D1 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-M08D1 (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-M08D1.
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)
- T1/2(Up to approximately 24 months)
- AUC0-t(Up to approximately 24 months)
- CL (Clearance)(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug Antibody (ADA)(Up to approximately 24 months)
研究者
研究点 (2)
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