This is an open-label, Phase 1 clinical study to evaluate the safety, tolerability, PK profiles, and clinical activity of IV and PO arginine supplementation + SOC chemoimmunotherapy regimens in participants with PROC.
Must be at least 18 years of age
ECOG performance status of 0 or 1 (see Appendix A).
Patient must be a candidate for either cohort A or cohort B treatment backbone.
For patients enrolling on treatment cohort A, PD-L1 positivity must be ≥1. Patient's with PD-L1 positivity ≥1% can enroll in cohort B at physician's discretion.
History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid.
Patient unwilling/unable to receive daily arginine treatment (IV or oral)
Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks
Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required.
Rebecca Arend
Lead sponsor
University of Alabama at Birmingham
Sponsor institution