RecruitingPhase 1NCT06398418

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


Sponsor

Rise Therapeutics LLC

Enrollment

33 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests combining R-5780-01 — a new experimental compound — with an anti-PD-1 immune checkpoint inhibitor (a type of immunotherapy) in patients with advanced solid tumors that have stopped responding to standard treatments. **You may be eligible if...** - You have an advanced solid tumor (such as lung, kidney, colorectal, or other cancer) - Your cancer has progressed despite standard treatments - You are at least 18 years old with adequate organ function - You are willing to undergo tumor biopsies as required by the protocol **You may NOT be eligible if...** - You have active, uncontrolled brain metastases - You have a serious autoimmune disease that could be worsened by immunotherapy - You have had severe side effects from prior anti-PD-1 therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-5780

Probiotic


Locations(1)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06398418


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