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

Rise Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor

Squamous Cell Cancer

Melanoma

Solid Tumor, Adult

Basal Cell Cancer

Adenoma

Treatments

Drug: R-5780

Study type

Interventional

Funder types

Industry

Identifiers

NCT06398418

RISE R-5780-01

Details and patient eligibility

About

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.

Full description

Patients will take an oral dosage of probiotic (R-5780 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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.