drugset / Trial / NCT04089163
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
SequentialOpen-labelTreatment
Summary
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2 dose. Patients with recurrent HG NMIBC who are undergoing planned transurethral resection of bladder tumor (TURBT) will be enrolled into the study, subject to meeting all entry criteria.
Timeline
- Start
- 2019-12
- Primary completion
- 2022-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flucytosine | Small molecule | 220 mg/kg | Oral |
| Subject | Vocimagene Amiretrorepvec | Unknown | — | Intravenous |