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Recruiting Phase 1

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

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About this study

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.

Condition
Solid Tumor, Adult, Solid Tumor, Melanoma, Basal Cell Cancer, Squamous Cell Cancer, Adenoma
Tested
R-5780
Sponsor
Rise Therapeutics LLC

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Solid Tumor, Adult, Solid Tumor, Melanoma, Basal Cell Cancer, Squamous Cell Cancer, Adenoma
  • 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.

Exclusion 14

  • 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.

Where

2 sites, 2 recruiting

Sarah Cannon Research Institute

Denver, Colorado, United States

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.