NCT07107178尚未招募1 期
A Phase Ib Study of the Safety, Tolerability and Efficacy of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
未提供0 个研究点目标入组 58 人开始时间: 2025年8月8日最近更新:
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
- 58
- 主要终点
- Adverse events
研究概览
简要总结
The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with advanced melanoma,regardless of gender, aged between 18 and 75 years (inclusive).
Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy .
- •Adequate organ and hematologic function.
- •At least 1 extracranial measurable lesion.
- •An ECOG activity status score of 0-
- •A life expectancy of ≥ 3 months.
- •Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
- •Good compliance and willingness to follow up.
排除标准
- •Prior to first dose, received systemic antitumor therapy , scheduled major surgical procedure within 4 weeks , received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
- •A history of active autoimmune disease within the past 2 years.
- •A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities or LVEF<50%. A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
- •A severe acute or chronic infection when enrollment.
- •Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
- •Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
- •Clinically active CNS metastases or meningeal metastases.
- •A history of other type of malignancies.
- •Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
- •Poor compliance.
- •A history of alcohol/drugs abuse.
- •Current pregnancy or breastfeeding.
- •Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.
研究组 & 干预措施
dose escalation and expansion
Experimental
干预措施: BT02 (Drug)
结局指标
主要结局
Adverse events
时间窗: Through the study completion, an average of 2 years
Dose limited toxicity(DLT)
时间窗: Through the dose escalation phase, an average of 8 months
Maximum tolerable dose(MTD)
时间窗: Through the dose escalation phase, an average of 8 months
Recommended phase 2 dose(RP2D)
时间窗: Through the study completion, an average of 2 years
次要结局
- Objective response rate (ORR) on tumor assessments(Through the study completion, an average of 2 years)
- Progression-free survival (PFS) on tumor assessments(Through the study completion, an average of 2 years)
- Overall survival (OS)(Through the study completion, an average of 2 years)
- Duration of response (DoR) on tumor assessments(Through the study completion, an average of 2 years)
- Disease control rate (DCR) on tumor assessments(Through the study completion, an average of 2 years)
- ADA and NAb incidence(Through the study completion, an average of 2 years)
- Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level(Through the study completion, an average of 2 years)
- Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level(Through the study completion, an average of 2 years)
研究者
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