Clinical Trials
Ongoing Clinical Trials
Patient participation in clinical trials is critical in order to advance the therapies of tomorrow. We are developing our lead product candidate, Toca 511 & Toca FC, for cancers that have significant unmet medical needs.
NRG-BN006 Clinical Trial
The Brain Tumor Committee at NRG Oncology elected to conduct and sponsor the Toca 511 & Toca FC clinical trial in patients with newly diagnosed glioblastoma based on the merits of published clinical and preclinical data. The proposed NRG-BN006 Phase 2/3 trial is expected to begin enrollment in the second half of 2019. More information about this study will be available soon.
Toca 8 Clinical Trial
Based on the results of our preclinical studies and clinical trial evaluating Toca 511 & Toca FC in solid tumor cancers, we are planning a Phase 1b trial for patients with recurrent, high-grade non-muscle invasive bladder cancer (NMIBC). Trial activation is expected in 2019. For more information about this study, called Toca 8, please visit the Toca 8 clinical trial page.
Toca 6 Clinical Trial
Preclinical research has encouraged us to explore the potential therapeutic benefit of Toca 511 & Toca FC in multiple other solid tumor cancers. We have initiated a clinical trial, called Toca 6, involving intravenously delivered Toca 511 for the treatment of metastatic colorectal, pancreatic, renal, breast, lung and melanoma. For more information about this study, please visit the Toca 6 clinical trial page.
Toca 5 Clinical Trial
Tocagen is conducting a Phase 3 clinical trial, called Toca 5, for patients with recurrent high grade glioma, or HGG. Analysis of the Toca 5 trial results are under review and are planned to be presented at an upcoming medical conference.
New Clinical Trial Site Inquiries
Clinical trial sites interested in participating in a Tocagen trial can contact us here.
Expanded Access to Investigational, Unapproved Medicines
We believe that our fastest path to fulfill our commitment to patients is to focus on working with the FDA to complete the required clinical studies needed to demonstrate safety and effectiveness of our investigational therapy Toca 511 & Toca FC for multiple cancer indications. This focus on completing our clinical trials, will help us expeditiously achieve the best outcome for the greatest number of adults and children suffering from cancer.
Currently, Tocagen does not have an Expanded Access Program (EAP) for any advanced cancers. Details of our ongoing clinical trials are available on the clinical trials section of our website. We encourage patients to discuss their treatment options, including clinical trials, with their medical team, and contact any of the several patient advocacy organizations listed here for resources, research and support.
Clinical Trials for Pediatrics
We do not have any trials for pediatrics at this time. However, we remain committed to have trials in children/pediatrics in the future. Details of our ongoing clinical trials are available on the clinical trials section of our website. We encourage patients to discuss their treatment options, including clinical trials, with their medical team, and contact any of the several patient advocacy organizations listed below for resources, research and support.
Encouraging Results in Recurrent HGG Patients
Inspire the Future
Across our three ascending-dose Phase 1 trials, Tocagen has treated 127 patients with recurrent high grade glioma, or HGG, with Toca 511 & Toca FC. In these trials, potential benefits were observed, including durable objective responses, extended overall survival and a favorable safety profile. The recommended dose for future trials was also identified. Based on these Phase 1 clinical trial results, a pivotal Phase 3 clinical trial for patients with first or second recurrent HGG undergoing resection is ongoing.
The U.S. Food and Drug Administration (FDA) granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of HGG. These designations are granted to new products that treat serious diseases or conditions and demonstrate the potential to address an unmet medical need.
Tocagen has also obtained a $2 million Orphan-Drug Grant to support the Toca 5 trial and received Orphan-Drug Designation for the treatment of malignant glioma. Orphan-Drug Designation is a designation for a product that treats a rare disease or condition and which, if the product receives the first FDA approval for that disease or condition, may result in a period of regulatory exclusivity, subject to some exceptions.