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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Rise Therapeutics LLC
Study ID
NCT06398418
Phase
PHASE1
Status
Recruiting

Conditions

  • Adenoma
  • Basal Cell Cancer
  • Melanoma
  • Solid Tumor
  • Solid Tumor, Adult
  • Squamous Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • R-5780 — DRUG
    Probiotic

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open Label
    R-5780 Probiotic

Primary Outcome Measure

Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration [ Time Frame: Baseline through Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research InstituteNashvilleTennessee37203
Sam Howell
615-478-2104
Benjamin Garmezy, MD (PRINCIPAL_INVESTIGATOR)

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