Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-29
Brief Title:
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors Checkpoint Protein on Immune Cells Called T Cells in Patients With Solid Tumors
Sponsor:
Rise Therapeutics LLC
Organization:
Rise Therapeutics LLC
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None