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New treatment option for Solid Tumor, Adult
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
ClinicalTrials.gov ID: NCT06398418
What this study is testing
What is R-5780?
R-5780 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- Life expectancy of greater than 3 months
You likely can't join if
- Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in...
- 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
See the full eligibility 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...
- 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...
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- people 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.
- 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...
- 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
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.