RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06398418

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Janet Stephens, PhD

CONTACT

650-417-8556

jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

215-923-1818

cfreguia@risetherapeutics.com

Study Locations (Sites)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Rise Therapeutics LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Solid Tumors

Additional Relevant MeSH Terms

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