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R-5780 Probiotic with PD-1 Checkpoint Inhibitors for Solid Tumors

This study is looking at the safety of a probiotic called R-5780 when given along with PD-1 checkpoint inhibitors (a type of medicine that helps your immune system fight cancer) to people with certain solid tumors. You might be able to join if you are between 18 and 80 years old and have unresectable stage III or IV melanoma, basal cell carcinoma, squamous cell carcinoma, or other solid tumors. The main goal is to see how safe R-5780 is and if it causes any side effects during the first four weeks. The study plans to enroll 33 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 33 participants.
What's involved
You would take an oral probiotic (R-5780), report how you feel, and have your tumors measured by a doctor. Blood and stool samples will be collected to check for inflammation and probiotic levels.
Compensation
Not stated in the trial record.
Follow-up
The primary safety measurements are taken from the start of the study through Week 4.

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NCT06398418

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Rise Therapeutics LLC
~33 participants
Updated 2025-09-04 on ClinicalTrials.gov
What's tested:R-5780

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration
Measured over Baseline through Week 4

Conditions

Solid Tumor, Adult
Solid Tumor
Melanoma
Basal Cell Cancer
Squamous Cell Cancer
Adenoma

Explore related trials

Basal Cell CarcinomaMelanomaSolid NeoplasmSquamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Who to contact

Janet Stephens, PhD
[email protected]
650-417-8556
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

What this trial measures

  • Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administrationBaseline through Week 4

    To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)