Colorectal NeoplasmsPhase 1/2NCT04194034
Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer
A Phase 1/2 study testing TG6002 and Flucytosine (5-FC) in people with Colorectal Neoplasms, run by Transgene at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- TG6002 and Flucytosine (5-FC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Jan 2020to 23 Feb 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable metastatic CRC with at least one measurable liver metastasis
- At least one liver metastasis amenable to biopsy
- Patients previously exposed to fluoropyrimidine-based chemotherapy
- (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
- (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy.
- Aged ≥18 years
- Estimated life expectancy >3 months
- ECOG performance status ≤1
Who cannot join
- Predominant extrahepatic disease
- Symptomatic brain metastases or meningeal tumors
- Any contraindication to intrahepatic artery infusion procedure
- Received other investigational therapy or had surgery within 4 weeks of treatment initiation which would interfere with study treatment
- Received locoregional therapy for CRC within 4 weeks prior to treatment initiation
- Severe uncontrolled coagulopathy OR anticoagulant medication
Show all 9Show fewer
- Antiviral therapy active on vaccinia virus, e.g., ribavirin, interferon/pegylated interferon
- 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
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Centre Léon Bérard
Lyon, 69008
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: A Dose-escalation and Phase IIa Study of TG6002 Plus Flucytosine in Patients With Unresectable Colorectal Cancer With Liver Metastases
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.
Read more
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- TG6002, Flucytosine (5-FC)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG6002Biological
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.
Flucytosine (5-FC)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TG6002 and flucytosine (5-FC) combination | Experimental | Not described Receives: Biological: TG6002; Drug: Flucytosine (5-FC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (Phase I part)
Incidence of Adverse events using CTCAE v5.0
Measured: Day 28
Disease Control Rate (Phase II part)
Proportion of patients whose tumour assessment is either complete response (CR), partial response (PR), or stable disease (SD)
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start17 Jan 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: Study has been terminated after Phase I part on 23 February 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194034
- Sponsor's protocol ID
- TG6002.03
- Status last verified
- Jun 2023
- First submitted
- 8 Dec 2019
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation and Phase IIa Study of TG6002 Plus Flucytosine in Patients With Unresectable Colorectal Cancer With Liver Metastases
- ClinicalTrials.gov ID
- NCT04194034
- Acronym / sponsor ID
- TG6002.03
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated after Phase I part on 23 February 2023
- Enrolment
- 15 participants (actual)
- Lead sponsor
- TransgeneIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG6002 and flucytosine (5-FC) combination | Experimental | Biological: TG6002, Drug: Flucytosine (5-FC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unresectable metastatic CRC with at least one measurable liver metastasis
- At least one liver metastasis amenable to biopsy
- Patients previously exposed to fluoropyrimidine-based chemotherapy
- (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
- (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy.
Key exclusion criteria (9 listed)
- Predominant extrahepatic disease
- Symptomatic brain metastases or meningeal tumors
- Any contraindication to intrahepatic artery infusion procedure
- Received other investigational therapy or had surgery within 4 weeks of treatment initiation which would interfere with study treatment
- Received locoregional therapy for CRC within 4 weeks prior to treatment initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG6002Phase 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. | Biological | TG6002 and flucytosine (5-FC) combination |
| 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. | Drug | TG6002 and flucytosine (5-FC) combination |
Primary outcome
Dose-limiting toxicities (Phase I part)
Time frame: Day 28
Incidence of Adverse events using CTCAE v5.0
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)
Results and safety
The study was stopped early (reason given: Study has been terminated after Phase I part on 23 February 2023). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TG6002 and Flucytosine (5-FC) in people with Colorectal Neoplasms, run by Transgene at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study has been terminated after Phase I part on 23 February 2023). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (Phase I part) (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.