A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Number of patients with dose limiting adverse events (Escalation cohort)
研究概览
简要总结
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.
To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926
Secondary Objectives:
To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.
To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.
To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
详细描述
The study duration for an individual patient will include a screening period for inclusion of up to 28 days, a treatment period, an end-of-treatment (EOT) visit around 30 days following the last administration of SAR428926, and at least one follow-up visit around 30 days after the EOT visit. The treatment period may continue until disease progression, intolerable toxicity, or investigator, Sponsor, or patient decision to discontinue therapy. Patients who discontinue treatment for reasons other than progression of disease will be followed every 3 months until progression, initiation of subsequent therapy, or until the primary analysis cutoff date, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR428926-Escalating cohort
SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities
干预措施: SAR428926 (Drug)
SAR428926 in triple negative breast cancer-Expansion Cohort 1
SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity
干预措施: SAR428926 (Drug)
SAR428926 in solid tumors-Expansion Cohort 2
SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity
干预措施: SAR428926 (Drug)
结局指标
主要结局
Number of patients with dose limiting adverse events (Escalation cohort)
时间窗: 4 weeks
Number of patients with corneal adverse events impacting study treatment (Escalation cohort)
时间窗: 8 weeks
Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)
时间窗: Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
次要结局
- Number of treatment emergent adverse events(Up to 3 years)
- Assessment of PK parameter: maximum concentration (Cmax)(2 months)
- Assessment of PK parameter: trough plasma concentration (Ctrough)(Every 2 weeks until approximately 14 weeks)
- Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day)(2 months)
- Assessment of PK parameter: accumulation ratio on AUC0-14(2 months)
- Assessment of PK parameter: clearance at steady state (CLss)(2 months)
- Assessment of PK parameter: time to reach maximum concentration (tmax)(2 months)
- Assessment of PK parameter: mean systemic clearance (CL)(2 months)
- Assessment of PK parameter: accumulation ratio on Cmax(2 months)
- Preliminary tumor response by RECIST v1.1 (Escalation)(2 months)
- Number of corneal events according to the presence or not of preventive measures(12 weeks)