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Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04194034
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : August 25, 2021
Information provided by (Responsible Party):

Brief Summary:

This study will include two parts:

  • Phase I part is a dose-escalation study to assess the safety of increasing doses of TG6002 in combination with oral flucytosine (5-FC) in consecutive cohorts of 3 to 6 patients with colorectal cancer and unresectable liver metastases according to a 3+3 design
  • Phase IIa part is an extension of the phase I part at the recommended phase II dose to evaluate the efficacy of TG6002 in combination with oral flucytosine (5-FC) in patients with colorectal cancer and unresectable liver metastases.

In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.

All patients will be followed until disease progression, death due to any cause or the date of data cut-off, whichever occurs first.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Biological: TG6002 Drug: Flucytosine (5-FC) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-escalation and Phase IIa Study of TG6002 Plus Flucytosine in Patients With Unresectable Colorectal Cancer With Liver Metastases
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Flucytosine

Arm Intervention/treatment
Experimental: TG6002 and flucytosine (5-FC) combination Biological: TG6002

Phase I part: Dose escalation from 1 x 10E6 PFU to 1 x 10E9 PFU. Phase II part: Established recommended Phase II dose (RP2D).

Intrahepatic arterial (IHA) administration on Day 1 within a 14-day cycle of TG6002/5-FC combination treatment.

A second cycle of TG6002/5-FC combination starting with TG6002 (IHA) administration at the same dose on Day43 can be initiated if no progressive disease or Dose Limiting Toxicity event in between; maximum 2 cycles of TG6002/5-FC combination treatment for each patient.

Drug: Flucytosine (5-FC)

Oral administration 4 times per day at the total dose of 200 mg/kg/day for 10 consecutive days per 14-day cycle of TG6002/5-FC combination.

A second cycle of TG6002/5-FC combination will be initiated if no progressive disease or Dose Limiting Toxicity event in between.

Primary Outcome Measures :
  1. Dose-limiting toxicities (Phase I part) [ Time Frame: Day 28 ]
    Incidence of Adverse events using CTCAE v5.0

  2. Disease Control Rate (Phase II part) [ Time Frame: Week 10 ]
    Proportion of patients whose tumour assessment is either complete response (CR), partial response (PR), or stable disease (SD)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Unresectable metastatic CRC with at least one measurable liver metastasis
  2. At least one liver metastasis amenable to biopsy
  3. Patients previously exposed to fluoropyrimidine-based chemotherapy
  4. (Phase I) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy, or, in the UK only, patients on or entering a period of clinical observation without treatment
  5. (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy.
  6. Aged ≥18 years
  7. Estimated life expectancy >3 months
  8. ECOG performance status ≤1

Exclusion Criteria:

  1. Predominant extrahepatic disease
  2. Symptomatic brain metastases or meningeal tumors
  3. Any contraindication to intrahepatic artery infusion procedure
  4. Received other investigational therapy or had surgery within 4 weeks of treatment initiation which would interfere with study treatment
  5. Received locoregional therapy for CRC within 4 weeks prior to treatment initiation
  6. Severe uncontrolled coagulopathy OR anticoagulant medication
  7. Antiviral therapy active on vaccinia virus, e.g., ribavirin, interferon/pegylated interferon
  8. Immunosuppression due to immunosuppressive medication including steroids equivalent to prednisolone >10mg/day taken for more than 4 weeks within 3 months prior to TG6002 treatment initiation
  9. Patients treated with 3 or more anti-hypertensive agents AND/OR patients with signs of advanced hypertensive disease, such as left ventricular hypertrophy, hypertensive encephalitis or history of hemorrhagic stroke.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194034

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Contact: Transgene EU, Clinical Operations Department +333 88 27 91 00 clinicaltrials@transgene.fr

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Centre Léon Bérard Recruiting
Lyon, France, 69008
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94800
United Kingdom
NHS St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
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Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT04194034    
Other Study ID Numbers: TG6002.03
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antifungal Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action