R-5780 with PD-1 blockers for adults with advanced melanoma and other solid tumors
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
This Phase 1 test will try an oral probiotic called R-5780 together with PD-1 checkpoint inhibitors to see if adults with advanced solid tumors can tolerate it safely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rise Therapeutics LLC Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, prednisone |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06398418 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label study gives an oral probiotic (R-5780) to adults who are already receiving PD-1 pathway checkpoint inhibitors for unresectable stage III/IV melanoma, basal cell carcinoma, squamous cell carcinoma, or other solid tumors refractory to PD-1/L1 therapy. Participants will take R-5780 and provide patient-reported overall well-being while physicians measure tumors by CT or MRI per RECIST v1.1. Blood and stool samples will be collected to measure inflammatory markers and to track fecal levels of the probiotic. The primary focus is safety and tolerability, with exploratory biological readouts on the microbiome and inflammation.
Who should consider this trial
Good fit: Adults 18–80 with unresectable stage III/IV melanoma, basal cell carcinoma, squamous cell carcinoma, or other solid tumors who are currently on PD-1/L1 therapy, have disease refractory to prior checkpoint inhibitor cycles, have ECOG 0–2, and a life expectancy over three months.
Not a fit: Patients not on PD-1/L1 therapy, with resectable disease, poor performance status (ECOG >2), life expectancy ≤3 months, or who cannot give informed consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If safe, R-5780 could reduce treatment-related inflammation or improve how patients feel on PD-1 therapy and might favorably influence immune responses to tumors.
How similar studies have performed: Modifying the gut microbiome to alter immunotherapy responses has shown encouraging preclinical results and limited clinical signals, but using a specific oral probiotic like R-5780 with PD-1 inhibitors is largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Janet Stephens, PhD
- Email: jstephens@risetherapeutics.com
- Phone: 650-417-8556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.