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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194034
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Transgene

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 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.





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
Criteria

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 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

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


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

Locations
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United Kingdom
NHS St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Transgene
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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: March 11, 2020
Last Verified: March 2020
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Flucytosine
Antifungal Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action