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A Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Solid Tumors (Toca6)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Tocagen Inc.
Information provided by (Responsible Party):
Tocagen Inc. Identifier:
First received: October 12, 2015
Last updated: September 9, 2016
Last verified: September 2016
This is a multicenter, open label, single arm study of Toca 511 and Toca FC. Based on their cancer diagnosis (brain metastases from non small cell lung cancer or breast cancer; colorectal cancer with liver metastases; metastatic renal cell carcinoma; locally advanced or recurrent melanoma; locally advanced or metastatic pancreatic cancer or breast cancer [ie, other than resectable brain metastases]) subjects will receive Toca 511 either intravenously (IV) or intralesionally (IL). Up to 6 subjects will be enrolled for each disease group. In all but the melanoma group, Toca 511 will be administered by IV injection for 3 consecutive days (14 mL per day); in the melanoma group, at least 3 subjects may receive Toca 511 by IV injection (same dosing regimen as the other 3 groups), and at least 3 subjects will receive Toca 511 by IL injection (approximately 0.1 mL to 4 mL for 5 consecutive days). Based on the disease group, subjects will have either multiple core biopsies or a resection of a metastatic lesion (primary for subjects with renal cell carcinoma undergoing debulking nephrectomy), approximately 14 to 28 days after Toca 511 administration. A portion of the resected or biopsied tumor sample will be evaluated for the presence of Toca 511 vector sequences and markers for disease characteristics. After recovery from the biopsy or surgery (approximately 4-6 weeks from Toca 511 treatment start), subjects will begin the first cycle of oral Toca FC (ie, a 7 day course of 220 mg/kg/day; thereafter, cycles of 7-day courses of Toca FC will be repeated approximately every 6 weeks). Toca FC may be continued alone or in conjunction with standard therapy (other investigational treatments prohibited). One or more disease groups may be expanded to allow replacement of subjects or to provide a better assessment of efficacy. Subjects will be followed for safety for up to 15 years as required by regulatory authorities. In addition, subjects will be followed for efficacy (objective response and survival).

Condition Intervention Phase
Metastatic Colorectal Cancer Metastatic Renal Cell Carcinoma Metastatic Melanoma Brain Metastasis Locally Advanced or Metastatic Pancreatic Cancer Locally Advanced or Metastatic Breast Cancer Biological: Toca 511 Drug: Toca FC Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Tocagen Inc.:

Primary Outcome Measures:
  • Number of patients with vector deposition detected in the resected tumor specimens following administration of Toca 511 [ Time Frame: Assessment of virus deposition 6 months after FPFV ]

Secondary Outcome Measures:
  • Number of patients who received Toca 511 and Toca FC with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Assessment of safety 6 months after FPFV ]
  • Number of surviving patients who do not have documented tumor progression following treatment [ Time Frame: Evaluate response 2 years after FPFV ]

Estimated Enrollment: 26
Study Start Date: July 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toca 511/Toca FC

Toca 511: For subjects allocated to intravenous administration of Toca 511, 14 mL will be administered daily for 3 consecutive days. For subjects allocated to intralesional administration of Toca 511, 0.1 mL to 4 mL will be administered to the same lesion(s) daily for 5 days.

Toca FC: After recovery from resection or biopsy (approximately 6 weeks from Toca 511), subjects will begin a 7 day course of oral Toca FC at 220 mg/kg/day, to be repeated approximately every 6 weeks.

Biological: Toca 511
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
Other Names:
  • vocimagene amiretrorepvec
  • RRV
  • retroviral replicating viral
Drug: Toca FC
Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with "TOCA FC" embossed on one side and "500" embossed on the other side
Other Names:
  • Flucytosine
  • 5-FC
  • 5-Fluorocytosine


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Metastatic solid tumor, including:

    • Subjects with brain metastases with a primary tumor of non small cell lung cancer (NSCLC) or breast cancer, suitable for planned resection of brain metastasis
    • Subjects with metastatic colorectal cancer with liver metastases suitable for core biopsy
    • Subjects with renal cell carcinoma presenting with metastatic disease, with primary planned for resection or who have metastatic lesions suitable for biopsy
    • Subjects with locally advanced/recurrent melanoma with skin or nodal disease suitable for resection
    • Subjects with locally advanced or metastatic pancreatic cancer or breast cancer (other than brain metastases) with lesions that are amenable to biopsy
  2. Subject has given written informed consent
  3. Subject is between 18 years old and 90 years old, inclusive
  4. Laboratory values adequate for subject to undergo surgery or biopsy, including:

    • Platelet count ≥ 100,000/mm3
    • Hgb ≥ 10 g/dL
    • Absolute neutrophil count (ANC) ≥ 1,500/mm3
    • Normal PT/PTT (subnormal PT/PTT acceptable)
    • Adequate liver function, including: total bilirubin ≤ 1.5 x ULN (unless known Gilbert's syndrome); ALT ≤ 2.5 x ULN (≤ 5.0 x ULN in subjects with liver metastases)
  5. The subject has an ECOG Performance Status 0 to 1
  6. The subject must be a candidate for biopsy or resection of at least one lesion
  7. Subject must have a life expectancy of > 3 months

Exclusion Criteria:

  1. History of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment.
  2. The subject has or had any active infection requiring antibiotic, antifungal or antiviral therapy within the past 2 weeks
  3. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery
  4. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas)
  5. The subject received any investigational treatment within the past 2 weeks or prior immunotherapy or antibody therapy within the past 45 days and/or has not recovered from toxicities associated with such treatment
  6. Severe pulmonary, cardiac or other systemic disease, specifically:

    New York Heart Association > Grade 2 congestive heart failure which is not controlled on standard therapy within 6 months prior to study entry Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to CTCAE 4.03)

  7. Subjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02576665

Contact: Jolene Shorr (858) 412-8467
Contact: Mary Lovely (858) 412-8473

United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Jamie Merchan, MD    305-243-1287   
Contact: Tamara Leon Aliz    (305) 243-0865   
Sponsors and Collaborators
Tocagen Inc.
Principal Investigator: Jaime R Merchan, MD University of Miami
  More Information

Responsible Party: Tocagen Inc. Identifier: NCT02576665     History of Changes
Other Study ID Numbers: Tg 511-15-02
Study First Received: October 12, 2015
Last Updated: September 9, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Carcinoma, Renal Cell
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Antifungal Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 27, 2017