A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With either gender aged ≥ 18 years,
- •Has a confirmed diagnosis of advanced solid tumor(s),
- •The subject has received and failed standard-of-care anti-cancer therapy
- •Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
排除标准
- •Has any ongoing toxicity from previous anti-cancer treatments
- •Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s)
- •History of another primary malignancy within the last three years
研究组 & 干预措施
BGM-2121
干预措施: BGM-2121 (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: From first dose through the DLT evaluation period (28 days)
Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria.
Treatment Discontinuation Due to Drug-Related Adverse Events
时间窗: From first dose through study completion, an average of 1 year
Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0.
Incidence of Treatment-Emergent and Treatment-Related Adverse Events
时间窗: From first dose through 6 weeks after the last dose of study treatment
Incidence, type, and timing of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), graded per CTCAE v5.0.
Number of Participants With Grade ≥3 Laboratory Abnormalities
时间窗: From first dose through study completion, an average of 1 year
Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria
Changes in Electrocardiogram (ECG) Parameters
时间窗: From baseline through study completion, an average of 1 year
Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration.
次要结局
- Determination of Maximum Tolerated Dose (MTD) to establish RP2D(From first dose through the DLT evaluation period (28 days))
- Incidence of Anti-Drug Antibodies (ADAs)(From first dose through 6 weeks after the last dose of study treatment)
- Peak Serum Concentration (Cmax) of BGM-2121(From first dose through 30 days after the last dose)
- Area under Curve (AUC) of BGM-2121(From first dose through 30 days after the last dose)
- Objective Response Rate (ORR)(From baseline through study completion, an average of 1 year)
- Progression-Free Survival (PFS)(From first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 weeks)