drugset / Trial / NCT04089163

A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)

NCT04089163

Phase 1 Withdrawn Tocagen Inc.
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

EvaluationDrugModalityDoseRoute
Subject Flucytosine Small molecule 220 mg/kg Oral
Subject Vocimagene Amiretrorepvec Unknown Intravenous