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

NCT06398418 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RISE R-5780-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration

  To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)

  Baseline through Week 4

Secondary Outcomes (1)

• Scale (QOLS)

  Baseline through End of Study Day 112

Study Arms (1)

Open Label

OTHER

R-5780 Probiotic

Drug: R-5780

Interventions

R-5780 DRUG

Probiotic

Open Label

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Rise Therapeutics LLC: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Adenoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Glandular and Epithelial

Central Study Contacts

Janet Stephens, PhD

CONTACT

650-417-8556; jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

215-923-1818; cfreguia@risetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)