Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors.
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|ClinicalTrials.gov Identifier: NCT03724071|
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : October 23, 2019
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 colorectal 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|
|Colorectal Neoplasm Digestive System Neoplasm||Biological: TG6002 Drug: Flucytosine (5-FC, Ancotil)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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 1 x 10E9 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
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): NCT03724071
|Contact: Transgene EU, Clinical Operations Department||+ 33 3 88 27 91 firstname.lastname@example.org|
|Site No 0201||Recruiting|
|Site No 0101||Recruiting|
|Site No 0701||Recruiting|
|Site No 0702||Recruiting|