NCT06031584招募中1 期
A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Phase Ib: Recommended Phase II Dose (RP2D)
研究概览
简要总结
Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal 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 the protocol requirements;
- •No gender restrictions;
- •Age: ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
- •Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 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 (LVEF) ≥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;
- •Urine protein ≤2+ or ≤1000 mg/24h;
- •Albumin ≥30 g/L;
- •For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.
排除标准
- •Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
- •Previously treated with ADC drugs containing camptothecin derivatives as payloads;
- •History of severe cardiovascular or cerebrovascular diseases;
- •Active autoimmune or inflammatory diseases;
- •History of other malignancies within 5 years prior to the first dose;
- •Thrombotic events requiring therapeutic intervention within 6 months before screening;
- •Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
- •Poorly controlled hypertension despite antihypertensive medication;
- •Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
- •Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
- •History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
- •Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
- •Active hepatitis B virus (HBV) infection (exclusion criterion);
- •Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
- •Participation in another clinical trial within 4 weeks before the first dose;
- •Pregnant or lactating women;
- •Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
Study treatment
Experimental
Participants received BL-M07D1 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
干预措施: BL-M07D1 (Drug)
结局指标
主要结局
Phase Ib: 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.
Phase II: 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
- Phase Ib/II: Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Phase Ib: Objective response rate (ORR)(Up to approximately 24 months)
- Phase Ib/II: Disease control rate (DCR)(Up to approximately 24 months)
- Phase Ib/II: Duration of response (DOR)(Up to approximately 24 months)
- Phase II: Progression-free survival (PFS)(Up to approximately 24 months)
- Phase Ib/II: Tmax(Up to approximately 24 months)
- Phase Ib/II: Cmax(Up to approximately 24 months)
- Phase Ib: T1/2(Up to approximately 24 months)
- Phase Ib: AUC0-t(Up to approximately 24 months)
- Phase Ib: CL(Up to approximately 24 months)
- Phase Ib/II: Ctrough(Up to approximately 24 months)
- Phase Ib/II: Anti-drug antibody (ADA)(Up to approximately 24 months)
研究者
研究点 (1)
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