An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)
研究概览
简要总结
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
详细描述
Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Male or female patients aged >/=18 years
- •Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
- •Adequate bone marrow, liver, and renal functions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •In the addition to the above Part 3 (US Only) and Part 4 (US Only)
- •Must be eligible to use pembrolizumab per USPI
排除标准
- •Active clinically serious infections of events > Grade 2
- •Subjects who have new or progressive brain or meningeal or spinal metastases.
- •Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
- •Major surgery or significant trauma within 4 weeks before the first dose of study drug
- •Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.
研究组 & 干预措施
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
干预措施: Keytruda (Drug)
Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)
Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
干预措施: VIP152 (BAY 1251152) (Drug)
Dose expansion of VIP152 (BAY 1251152) / PART 2
Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
干预措施: VIP152 (BAY 1251152) 30 mg (Drug)
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
干预措施: Keytruda (Drug)
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
干预措施: VIP152 (BAY 1251152) 15 mg (Drug)
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
干预措施: VIP152 (BAY 1251152) 30 mg (Drug)
结局指标
主要结局
Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab)
时间窗: Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days
AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Number of participants with adverse events as a measure safety and tolarability
时间窗: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
次要结局
- Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL)(Up to 3 Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months))