Clinical Trials
Istari Oncology is committed to developing pathways that lead to the successful clinical development and registration of PVSRIPO and other technologies for the treatment of cancer.
Successful clinical trials are required to gain regulatory approval for new medications to treat and beat cancer.
PVSRIPO
Following extensive IND-enabling testing, the FDA approved IND 14,735 on June 19, 2011 for Intratumoral Administration of Oncolytic Poliovirus against recurrent GBM. The first patient in the single-center Phase 1 recurrent GBM clinical trial (NCT01491893) was treated May 11, 2012. The FDA granted PVSRIPO breakthrough therapy and Orphan Drug Designation in 2016.
Current Clinical Trials
- Recruiting
Melanoma:
PVSRIPO for Patients With Unresectable MelanomaPediatric Brain Tumors:
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in ChildrenBreast Cancer:
Examining Bioactivity of PVSRIPO in Invasive Breast Cancer - Recruiting Soon
Recurrent Glioblastoma:
PVSRIPO and Pembrolizumab in Patients With Recurrent Glioblastoma - Ongoing/Not Recruiting
PVSRIPO in Recurrent Malignant Glioma
PVSRIPO for Recurrent Glioblastoma (GBM)
ATC
We are currently evaluating D2C7 in a dose escalation Phase 1 study, which began in 2014. The study is scheduled to end in 2020. A combination trial, D2C7 plus atezolizumab, is currently enrolling.