RecruitingPhase 1NCT06398418

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

Sponsor

Rise Therapeutics LLC

Enrollment

33 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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 Criteria14

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.