A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Safety of Allocetra-OTS
研究概览
简要总结
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.
详细描述
Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).
Allocetra-OTS will be administered systemically or locally (intravenous [IV] or intraperitoneal [IP]) according to the tumor location.
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
- •Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.
- •Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
- •Patients must have measurable disease.
- •Age ≥ 18 years old.
- •ECOG performance status ≤
- •Adequate renal function, hepatic function, and bone marrow function.
排除标准
- •Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
- •Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
- •[For patients in Stage 2] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
研究组 & 干预措施
Stage 1 (Allocetra-OTS monotherapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration.
干预措施: Allocetra-OTS (Drug)
Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg.
干预措施: Allocetra-OTS (Drug)
Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg.
干预措施: Nivolumab (Drug)
Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg.
干预措施: Allocetra-OTS (Drug)
Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Safety of Allocetra-OTS
时间窗: 3-5 weeks
Characterize the safety of Allocetra-OTS based on the dose-limiting toxicities (DLTs) of Allocetra-OTS as monotherapy or in combination with anti-PD1 therapy.
次要结局
- Overall Response Rate (ORR)/Best Overall Response Rate (BORR)(12 months)
- Clinical benefit rate (CBR)(12 months)
- Progression-free survival (PFS)(12 months)
- Duration of response (DoR)(12 months)
- Overall survival (OS)(12 months)
- Time to response (TTR)(12 months)