NCT06398418 R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
| NCT ID | NCT06398418 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rise Therapeutics LLC |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2029-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2025-08-01 with a primary completion date of 2029-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06398418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06398418 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06398418 currently recruiting?
Yes, NCT06398418 is actively recruiting participants. Contact the research team at jstephens@risetherapeutics.com for enrollment information.
Where is the NCT06398418 trial being conducted?
This trial is being conducted at Denver, United States, Nashville, United States.
Who is sponsoring the NCT06398418 clinical trial?
NCT06398418 is sponsored by Rise Therapeutics LLC. The trial plans to enroll 33 participants.