NCT03471351终止1 期
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of RP6530, a Novel PI3K δ/γ Dual Inhibitor Given in Combination With an Anti-PD-1 Therapy, Pembrolizumab in Adult Patients With Relapsed or Refractory cHL
Rhizen Pharmaceuticals SA3 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL
研究概览
简要总结
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.
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
- •Age ≥18 years on the day of signing informed consent.
- •Histologically confirmed diagnosis of cHL.
- •Disease status as defined as.
- •Refractory patients who are naïve to anti-PD-1/PDL-1 therapy OR Relapsed after 3 or more lines of therapies; and are naïve to anti-PD-1/PDL-1 therapy OR
- •Patients currently on Pembrolizumab and achieve a less than complete response
- •Must have ECOG performance status of 0 or 1
- •At least one bi-dimensional measurable lesion with minimum measurement of > 15 mm in the longest diameter.
- •Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.
- •Adequate bone marrows, liver and renal function as assessed by the following laboratory requirements. Hemoglobin ≥8.0 g/dL (may not be transfused or treated with erythropoietin in preceding week to maintain or exceed this level)
- •Absolute neutrophil count (ANC) ≥1,000/µL
- •Platelet count ≥75,000/μL
- •Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
- •ALT and AST ≤2.5 x ULN
- •Serum creatinine ≤ 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula)
- •Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
- •Provide written informed consent prior to any study-specific screening procedures.
- •Willingness and capability to comply with the requirements of the study.
排除标准
- •Patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1,
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- •Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ≥ 14 days prior to C1D1);
- •Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D
- •Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D
- •Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
- •Pregnancy or lactation.
- •Known clinically active CNS involvement.
- •Evidence of active Hepatitis B, active Hepatitis C infection (HCV) or cytomegalovirus (CMV) or known history of HIV.
- •Subjects with concomitant second malignancies
- •Patient with any active immune toxicity of Grade 1 or greater or any other severe or Grade 3 treatment-related adverse event.
- •History of Grade 4 anaphylactic reaction to monoclonal antibody therapy.
研究组 & 干预措施
Tenalisib+Pembrolizumab
Experimental
Participants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion.
干预措施: Tenalisib (Drug)
Tenalisib+Pembrolizumab
Experimental
Participants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL
时间窗: 21 days
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment.
次要结局
- Duration of Response (DoR) with Tenalisib and Pembrolizumab combination(12 weeks)
- Maximum observed plasma concentration (Cmax)(21 days)
- Progression free survival (PFS) with Tenalisib and Pembrolizumab combination(12 weeks)
- Overall response rate (ORR) with Tenalisib and Pembrolizumab combination(12 weeks)
- Conversion Rate with Tenalisib and Pembrolizumab combination(12 weeks)
- Proportion of patients achieving CR and PR with Tenalisib and Pembrolizumab combination(12 weeks)
研究者
研究点 (3)
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