RECRUITING

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

Description

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

Solid Tumor, AdultSolid TumorMelanomaBasal Cell CancerSquamous Cell CancerAdenoma
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Related Conditions:

Solid Tumor, AdultSolid TumorMelanomaBasal Cell CancerSquamous Cell CancerAdenoma

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rise Therapeutics LLC,

Study Record Dates

2027-12-31