NCT04978779终止1 期
An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
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 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome
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
- •Adequate bone marrow, liver, and renal functions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Diseases as defined below:
- •Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥1 prior therap(ies) and the last prior regimen must have included venetoclax plus an anti-CD20 antibody and/or a BTKi and did not produce complete remission. Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥2 prior regimens and are intolerant to BTKi and/or venetoclax are also eligible.
- •Subjects with CLL transformed to DLBCL who have relapsed after, or been refractory, to at least 1 prior line of therapy for DLBCL
- •Subjects with CLL who are currently on an approved BTKi (monotherapy only) at the dose and schedule per the local label for ≥ 12 months who have only achieved SD, PR or PRL
排除标准
- •Active clinically serious infections of Grade > 2; requiring parenteral therapy
- •Subjects who have new or progressive brain or meningeal or spinal metastases.
- •Anticancer chemotherapy or immunotherapy during the study or within one week 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
Monotherapy of VIP152
Experimental
Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome
干预措施: VIP152 (Drug)
VIP152 in combination with BTKi
Experimental
Investigating VIP152 in combination with a BTKi in patients with CLL
干预措施: VIP152 (Drug)
VIP152 in combination with BTKi
Experimental
Investigating VIP152 in combination with a BTKi in patients with CLL
干预措施: BTKi (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 3 years
Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy
次要结局
- Time To Next Treatment(Up to 3 years)
- Overall Response Rate(Up to 3 years)
- Progression Free Survival(Up to 3 years)
- Duration of Response(Up to 3 years)
- Assessment of pharmacokinetics (PK) of VIP152(Cycle 1 Day 1 through Cycle 2 Day 1)
研究者
研究点 (5)
Loading locations...
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