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Trial Title:
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
NCT ID:
NCT06398418
Condition:
Solid Tumor, Adult
Solid Tumor
Melanoma
Basal Cell Cancer
Squamous Cell Cancer
Adenoma
Conditions: Official terms:
Neoplasms
Adenoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Basal Cell
Carcinoma, Basal Cell
Conditions: Keywords:
Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
R-5780
Description:
Probiotic
Arm group label:
Open Label
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.
Detailed description:
Patients will take an oral dosage of probiotic (R-3750 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Rise Therapeutics LLC
Agency class:
Industry
Source:
Rise Therapeutics LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398418
