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

Launched by RISE THERAPEUTICS LLC · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called R-5780-01, is examining a new probiotic treatment (R-5780) for patients with solid tumors, including melanoma and certain types of skin cancer, who are already receiving a specific type of immunotherapy known as PD-1 checkpoint inhibitors. The main goal is to find out if this probiotic is safe to take alongside these treatments. The study is currently not recruiting participants, but it will focus on adults aged 18 to 80 who have advanced stages of these cancers and have not responded to previous treatments.

To participate, individuals must have a life expectancy of at least three months and must be able to understand and sign a consent form. They should also have measurable disease that can be tracked through imaging tests. However, there are several criteria that would exclude someone from joining the trial, such as having serious medical conditions, certain infections, or a history of specific cancer treatments. If eligible, participants can expect to be monitored closely for their safety and how well they respond to the probiotic alongside their current cancer treatment.

Gender

ALL

Eligibility 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.