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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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.

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06398418
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rise Therapeutics LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma Recurrent, Basal Cell Cancer, Squamous Cell Cancer
Additional Details

Patients will take an oral dosage of probiotic (R-3750 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.

Arms & Interventions

Arms

Other: Open Label

R-5780 Probiotic

Interventions

Drug: - R-5780

Probiotic

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Janet Stephens, PhD

[email protected]

650-417-8556

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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