Tests R-5780 probiotic with PD-1 inhibitors in adults with solid tumors
Tests an oral probiotic, R-5780, alongside a PD-1 inhibitor in adults with solid tumors.
Plain-language title generated from the registry record
Registry title: R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
Key facts
- Where
- Denver and Nashville, United StatesSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06398418, who can take part
Where in United States
- Sarah Cannon Research InstituteDenver, United StatesTaking people
- Sarah Cannon Research InstituteNashville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rise Therapeutics LLC
- Trial code
- NCT06398418
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Treatment with systemic broad-spectrum antibiotics; 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; More than 4 prior systemic therapies; 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; Other cancer medications during treatment period are not permitted; 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; 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; Enrollment in other clinical trials.