NCT03724071

Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors.

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.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Transgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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) 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.

Conditions

• Colorectal Neoplasm
• Digestive System Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	TG6002	Phase I, Arm A: Dose escalation from 1 x 10E6 PFU to 1 x 10E9 PFU; Phase I, Arm B: Dose escalation from 1 x 10E9 PFU to 1 x 10E10 PFU; Phase II: Established recommended Phase II dose (RP2D) Administration intravenously on Days 1, 8 and 15 (Phase I, Arm A) or on Days 1, 3 and 5 (Phase I, Arm B). Three intravenous infusions at the Dose Recommended for Phase 2 (RP2D) in Phase IIa. 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 for a total of 10 days (Phase I, Arm B) or 16 days (Phase I, Arm A). An extension of the 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.

Timeline

• Start date: 2018-10-16
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2018-10-30
• Last updated: 2023-06-23

Locations

7 sites across 3 countries: Belgium, France, Spain