2024-516711-24-00招募中2 期
A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Everimmune
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI CTCAE version 5.0. - Dose reductions and interruptions. Phase 2: - ORR per iRECIST
研究概览
简要总结
Phase 1: Characterize the safety profile and tolerability of repeated doses of Oncobax®-AK, administered in combination with PD-L1-based chemo-immunotherapy in metastatic NSCLC or RCC patients deficient in Akkermansia Phase 2: Characterize the efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients and deficient in Akkermansia
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytologically confirmed Stage IV NSCLC or clear cell RCC.
- •Hemoglobin ≥90 g/L.
- •Neutrophil count ≥1.0 x 10^9/L.
- •Platelet count ≥75 x 10^9/L.
- •Lymphocyte count > 0.5 x 10e^9/L.
- •Albumin >30 g/L.
- •A wash-out period of 5 half-lives or more since the last dose administered of any investigational medicinal products or chemotherapy received previously.
- •For patients of child-bearing potential, commitment to use a birth control method with a failure rate of less than 1% per year, during the entire treatment period AND for at least 4 months after the last dose of ICI (for NSCLC patients) OR at least 5 months after the last dose of nivolumab (for RCC patients).
- •Signed informed consent form.
- •Patient eligible for SOC PD-L1 based immunotherapy or chemo-immunotherapy (for NSCLC) and ipilimumab + nivolumab (for RCC)).
- •NSCLC cohort-specific criterion: best tumor response (by iRECIST) as stable disease (SD) between 12 and 18 weeks after initiation of first line PD-L1-based immunotherapy or chemo-immunotherapy.
- •RCC cohort-specific criterion: intermediate- or poor-risk newly diagnosed RCC patients (clear cell histology).
- •Negative stool polymerase chain reaction (PCR) test for Akkermansia (A. muciniphila and A. massiliensis) as defined in paragraph 11.2.7.
- •of the protocol.
- •NSCLC cohort-specific criterion: PD-L1 expression data ≥ 1%.
- •At least one measurable (target) lesion per iRECIST.
- •Eastern Cooperative Oncology Group (ECOG) performance status = 0-
- •Age >18 years.
排除标准
- •Symptomatic brain metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period.
- •Pregnancy or breast-feeding.
- •Active inflammatory bowel disease and/or any medical condition that alters the integrity of the intestinal barrier.
- •Other co-morbidities that, in the opinion of the Investigator, may place the patient at a higher risk of treatment-related AEs.
- •Inability to comply with protocol-specific assessments.
- •Patient is subject to any of the following procedures: ward of court, trusteeship, supervision order, applied mandate of future protection.
- •Alanine aminotransferase (ALT) >5 times the upper limit of normal range (ULN).
- •Calculated creatinine clearance <40 mL/min.
- •Auto-immune diseases requiring systemic therapy.
- •Immunosuppressive therapy (>10 mg prednisone/day equivalent) within 4 weeks of signed informed consent.
- •Known allergy to Oncobax®-AK excipients.
- •Radiotherapy (>30 Gy) to the lung(s) within 6 months of signed informed consent.
- •Active infection. A 4-week delay must have elapsed between the resolution of any systemic infection and the initiation of Oncobax®-AK administration.
- •Vaccination with a live attenuated virus, other than influenza, within 6 months of signed informed consent.
结局指标
主要结局
Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI CTCAE version 5.0. - Dose reductions and interruptions. Phase 2: - ORR per iRECIST
Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI CTCAE version 5.0. - Dose reductions and interruptions. Phase 2: - ORR per iRECIST
次要结局
- Phase 2: - PFS9, OS12, DOR. - AEs, TEAEs, related TEAEs, SAEs, DLTs, per NCI-CTCAE version 5.0. - Dose reductions and interruptions
研究者
Alain Thibault
Scientific
Everimmune
研究点 (6)
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