NCT07841925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 Locally Advanced or Metastatic Melanoma 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
- 1
- 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 study to explore the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic melanoma 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 comply with protocol requirements;
- •No restriction on gender;
- •Age: ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Locally advanced or metastatic melanoma and other solid tumors;
- •Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose;
- •Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •Organ function levels must meet the requirements;
- •Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;
- •Urine protein ≤1+ or ≤1000 mg/24 h;
- •For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment ends;
- •Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
排除标准
- •Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose;
- •History of severe heart disease or cerebrovascular disease;
- •QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- •Active autoimmune diseases and inflammatory diseases;
- •Diagnosis of other malignancies within 5 years before the first dose;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
- •Hypertension poorly controlled by antihypertensive drugs;
- •Patients with poorly controlled blood glucose;
- •History of interstitial lung disease requiring hormone therapy, or current ILD or grade >= 2 radiation pneumonitis;
- •Severe impairment of respiratory function;
- •Active central nervous system metastasis;
- •Previous or concomitant central nervous system lesions;
- •Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1;
- •Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- •Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration;
- •Presence of pleural, abdominal, pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks before the first study drug administration;
- •Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc.;
- •Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose;
- •Pregnant or breastfeeding women;
- •Other circumstances in which the investigator considers 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 (1)
Loading locations...
相似试验
尚未招募
1 期
A Study of BL-M08D1 in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid TumorsGynecological TumorsSolid TumorsNCT07793825Sichuan Baili Pharmaceutical Co., Ltd.90
尚未招募
1 期
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid TumorsSolid TumorsGastrointestinal TumorsNCT07780318Sichuan Baili Pharmaceutical Co., Ltd.60
尚未招募
1 期
A Study of BL-M08D1 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma and Other Solid TumorsNasopharyngeal Carcinoma (NPC)Solid TumorsNCT07818486Sichuan Baili Pharmaceutical Co., Ltd.30
尚未招募
1 期
A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell LymphomaDiffuse Large B-Cell LymphomaNCT07818499Sichuan Baili Pharmaceutical Co., Ltd.204
尚未招募
2 期
A Study of BL-M08D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid TumorsHead and Neck Squamous Cell CarcinomasSolid TumorsNCT07788950Sichuan Baili Pharmaceutical Co., Ltd.30