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 : March 11, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: TG6002 and flucytosine (5-FC) combination||
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.
- 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)
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
|Contact: Transgene EU, Clinical Operations Department||+333 88 27 91 firstname.lastname@example.org|
|NHS St James's University Hospital||Recruiting|
|Leeds, United Kingdom, LS9 7TF|