NCT06398418招募中1 期
A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration
研究概览
简要总结
The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor (checkpoint protein on immune cells called T cells) with Solid Tumors.
详细描述
Patients will take an oral dosage of probiotic (R-5780 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age to 80
- •Ability to provide written informed consent
- •Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors.
- •Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1/L1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy.
- •Life expectancy of greater than 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Subjects must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response.
排除标准
- •Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess
- •Treatment with systemic broad-spectrum antibiotics.
- •No active viral infections.
- •Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases)
- •Secondary gastrointestinal motility disorders
- •History of solid organ transplant or bone marrow transplant
- •Prior CAR-T (chimeric antigen receptor) or allogeneic cellular therapy
- •Ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg/day)
- •Concurrent therapy with any other investigational agent, vaccine, or device
- •Pregnant or breastfeeding or planning to conceive or father a child during the trial period
- •Subjects with untreated brain metastasis. Treated brain metastasis are permitted if stable
- •More than 4 prior systemic therapies
- •Other cancer medications during treatment period are not permitted
- •Enrollment in other clinical trials.
研究组 & 干预措施
Open Label
Other
R-5780 Probiotic
干预措施: R-5780 (Drug)
结局指标
主要结局
Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration
时间窗: Baseline through Week 4
To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)
次要结局
- Scale (QOLS)(Baseline through End of Study Day 112)
研究者
研究点 (3)
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- Recent clinical milestones include Senhwa Biosciences completing Phase I trials for Silmitasertib with positive survival outcomes, and multiple companies reporting positive Phase II results for their respective candidates.
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- R-5780 is an orally delivered immunotherapy candidate designed to enhance the effectiveness of immune checkpoint inhibitors.
- The Phase 1 trial (NCT06398418) will assess the safety, drug exposure, and clinical activity of R-5780 in up to 33 participants with cancer.
- R-5780 leverages gut-regulated immune pathways to promote a robust anti-tumor T cell response, potentially overcoming resistance to existing therapies.last year