NCT07080242招募中1 期
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms
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
- 120
- 试验地点
- 24
- 主要终点
- Assess safety and tolerability of BL-M14D1
研究概览
简要总结
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms
详细描述
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment
- •Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting.
- •No prior topoisomerase inhibitor-based ADC therapy is permitted.
- •In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgroup): participants will be eligible based on documented positive DLL3 expression.
- •At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
- •Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy
- •No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
- •Adequate organ function
排除标准
- •Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
- •Participants who have received prior topoisomerase inhibitor-based ADC therapy
- •Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
- •Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc.
- •Participants with primary neoplasms in the central nervous system (CNS), active or untreated CNS metastases, spinal cord compression, or carcinomatous meningitis should be excluded. Active brain metastases are defined as untreated symptomatic brain metastases or untreated brain metastases requiring systemic corticosteroids and/or anticonvulsants to control CNS-related symptoms. Patients with brain metastases are eligible if they meet any of the following criteria:
- •untreated, asymptomatic brain metastases
- •previously treated brain metastases may participate provided they are clinically stable with local therapy (eg, surgery or radiotherapy, currently asymptomatic, no longer requiring corticosteroid treatment, and recovered from all local therapy-related adverse events, as determined by the investigator
- •Participated in another clinical trial within 4 weeks prior to first dose of study treatment
- •Participants who are pregnant or breastfeeding, or planning to become pregnant during the study
- •Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial
研究组 & 干预措施
Experimental BL-M14D1 administered Day 1 per cycle
Experimental
BL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks
干预措施: BL-M14D1 (Drug)
结局指标
主要结局
Assess safety and tolerability of BL-M14D1
时间窗: 18 months
SAEs, AESIs, TEAEs, death, TEAEs leading to discontinuation, DLTs, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, ECG parameters (including the change-from-baseline ECG parameters), and ECHO/MUGA findings
次要结局
- To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04)(18 months)
- To investigate the antitumor activity of BL-M14D1(18 months)
研究者
研究点 (24)
Loading locations...
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