A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207, a PSMA-targeting Bispecific γδ-T Cell Engager, Alone or With Low Dose Interleukin-2 or Pembrolizumab, in Patients With Therapy Refractory mCRPC
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Part 1 & Part 2: Frequency and severity of AEs
研究概览
简要总结
This is a phase 1, first-in-human study to evaluate Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer.
详细描述
This trial is an open-label Phase 1 dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory mCRPC.
The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).
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
- Male
- 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
LAVA-1207
LAVA-1207
干预措施: LAVA-1207 (Biological)
LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)
LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)
干预措施: LAVA-1207 (Biological)
LAVA-1207 plus Pembrolizumab
LAVA-1207 plus Pembrolizumab
干预措施: LAVA-1207 (Biological)
LAVA-1207 plus Pembrolizumab
LAVA-1207 plus Pembrolizumab
干预措施: LAVA-1207 plus Pembrolizumab (Biological)
结局指标
主要结局
Part 1 & Part 2: Frequency and severity of AEs
时间窗: Approximately 24 months
Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events and grading for CRS
Part 1: Frequency and type of DLT
时间窗: First 28 days of treatment
DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment.illness, or concomitant medications and is occurring during the first 28 days of treatment.
次要结局
- Part 1 & Part 2: Number of participants with an antitumor response(Approximately 24 months)
- Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies(Approximately 6 months)
- Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC)(Approximately 6 months)
- Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells(Approximately 24 months)