Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors.
|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: NCT03724071|
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : November 1, 2018
This study will include two parts:
- In the phase I part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG6002 in combination with oral flucytosine (5-FC) according to a 3+3 design in patients with advanced gastro-intestinal (GI) tumors.
- In the phase IIa part: evaluation of efficacy and further evaluation of safety of multiple administrations of TG6002 in combination with flucytosine (5-FC) in patients with colon cancer and liver metastases.
In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.
All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Digestive System Neoplasm||Biological: TG6002 Drug: Flucytosine (5-FC, Ancotil)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study of TG6002 (VV TK-RR-FCU1) Administered by Intravenous (IV) Infusions in Combination With Oral Flucytosine (5-FC) in Patients With Advanced Gastro-intestinal (GI) Tumors.|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
|Experimental: TG6002 and flucytosine combination||
Phase I: Dose escalation from 1 x 10E6 PFU to 3 x 10E8 PFU Phase II: Established recommended Phase II dose (RP2D)
Administration intravenously on Days 1, 8 and 15. An extension of the 28-day cycle of TG6002/5-FC combination can be repeated in case of evidence of patient benefit, defined as an objective radiological response or disease stabilization, and/or a clinically significant relief in patient's symptoms. Additional cycle(s) will start from 2 to 4 weeks following the last 5-FC intake.
Drug: Flucytosine (5-FC, Ancotil)
Administered orally at a dose of 200 mg/kg/day from Day 5 to 7, Day 12 to 14 and Day 19 to 28.
An extension of the 28-day cycle of TG6002/5-FC combination can be repeated in case of evidence of patient benefit, defined as an objective radiological response or disease stabilization, and/or a clinically significant relief in patient's symptoms. Additional cycle(s) will start from 2 to 4 weeks following the last 5-FC intake.
- Phase I part - Dose-limiting toxicities [ Time Frame: Day 28 ]Dose-limiting toxicities
- Phase II part - Overall response rate [ Time Frame: Day 43 ]Overall response rate according to Recist v1.1
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724071
|Contact: Transgene EU, Clinical Operations Department||+ 33 3 88 27 91 email@example.com|
|Site No 0201||Recruiting|
|Site No 0101||Recruiting|
|Site No 0501||Not yet recruiting|
|Site No 0701||Recruiting|
|Site No 0702||Recruiting|