NCT05865730招募中2 期
A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- EverImmune
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Objective Response Rate
研究概览
简要总结
Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.
Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
- •NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
- •NSCLC-specific criterion: PD-L1 expression > 50%
- •ECOG Performance Status = 0-1
- •Negative stool PCR test for Akkermansia
- •At least one measurable lesion per iRECIST
- •Hemoglobin ≥ 100 g/L
- •Albumin > 35 g/L
- •Signed informed consent
排除标准
- •Symptomatic brain metastases
- •AST or ALT > 5 x ULN
- •Calculated creatinine clearance < 45 ml/min
- •Auto-immune diseases requiring systemic therapy
- •Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
- •Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent
- •Active infection
- •Co-morbidities that may increase the risk of treatment-related adverse events
- •Inability to comply with protocol-specific assessments
结局指标
主要结局
Objective Response Rate
时间窗: 9 months
iRECIST
次要结局
- Progression-free survival(9 months)
研究者
研究点 (4)
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