Actively Recruiting
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
Led by Rise Therapeutics LLC · Updated on 2025-09-04
33
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Ability to provide written informed consent
- Diagnosis of unresectable stage III or IV melanoma, basal cell carcinoma, squamous cell carcinoma, or other solid tumors
- Refractory to anti-PD-1/L1 therapy with disease progression after at least two immune checkpoint inhibitor cycles or progression within 6 months while on therapy
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Presence of evaluable disease by CT or MRI or clinically apparent disease for monitoring response
You will not qualify if you...
- Serious medical, laboratory, or psychiatric conditions that would interfere with treatment or safety assessment
- Treatment with systemic broad-spectrum antibiotics
- Active viral infections
- Severe chronic diseases other than cancer (autoimmune or inflammatory diseases)
- Secondary gastrointestinal motility disorders
- History of solid organ or bone marrow transplant
- Prior CAR-T or allogeneic cellular therapy
- Ongoing systemic immunosuppressive therapy except prednisone 10 mg/day or less
- Concurrent use of other investigational agents, vaccines, or devices
- Pregnancy, breastfeeding, or plans to conceive/father a child during the trial
- Untreated brain metastases (stable treated brain metastases allowed)
- More than four prior systemic cancer therapies
- Use of other cancer medications during the study period
- Enrollment in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
J
Janet Stephens, PhD
CONTACT
C
Christian Freguia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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