Gastro-intestinal cancer MedDRA version: 21.1 Level: PT Classification code 10053548 Term: Gastrointestinal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
TRANSGENE S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient population for phase I: patients with advanced GI carcinomas having failed and/or intolerant to standard therapeutic options. Patients must have been previously exposed to fluoropyrimidine-based chemotherapy. - Patient population for phase IIa: patients with colorectal cancer and liver metastases having failed and/or intolerant to standard therapeutic options. In addition, the patient should not be candidate to a treatment with regorafenib. - Patient presenting with at least one measurable lesion according to RECIST 1.1 in Phase IIa part of the study (optional in the Phase I part) - ECOG performance status 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 49 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: - Previous irradiation of target tumor - MSI-High/dMMR colon cancer patients - Glomerular filtration rate 20 mg/day of equivalent prednisolone taken for more than 4 weeks within 3 months prior to TG6002 treatment initiation - History of severe exfoliative skin condition (e.g. eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to TG6002 treatment initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: determination of the recommended phase II dose Phase IIa: efficacy of multiple administrations of TG6002 in combination with flucytosine (or Ancotil or 5-FC);Secondary Objective: Phase I: safety and tolerability, efficacy according to RECIST 1.1, TG6002 blood pharmacokinetics, 5-FC, 5-FU and FBAL blood concentrations, detection of neutralizing anti-vaccinia virus antibodies, TG6002 viral shedding in saliva, urine and feces. Phase IIa: safety, evolution of various tumor marker blood levels over time, TG6002 blood pharmacokinetics, 5-FC, 5-FU and FBAL blood concentrations, detection of neutralizing anti-vaccinia virus antibodies.;Primary end point(s): Phase I: adverse events, serious adverse events, change in standard laboratory parameters and vital signs, dose-limiting toxicities. Phase IIa: overall response rate.;Timepoint(s) of evaluation of this end point: Phase I: Arm A: days 1, 2, 7 or 8, 14 or 15, 16, 29, 57, 85 and then every 8 weeks. Arm B: days 1, 2, 3, 5, 11, 19, 29, 57, 85 and then every 8 weeks. Phase IIa: days 43 and 85 and then every 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: 1) overall response rate Phase IIa: 1) adverse events, serious adverse events, change in standard laboratory parameters and vital signs, dose-limiting toxicities Phase I and phase IIa: 2) concentration of TG6002 in blood 3) concentration of 5-FC, 5-FU and FBAL in blood 4) detection of neutralizing anti-vaccinia virus antibodies in blood 5) TG6002 DNA in saliva, urine and feces.;Timepoint(s) of evaluation of this end point: Phase I: 1) days 43 and 85 and then every 8 weeks Phase IIa: 1) Arm A: days 1, 2, 7 or 8, 14 or 15, 16, 29, 57, 85 and then every 8 weeks Arm B: Arm B: days 1, 2, 3, 5, 11, 19, 29, 57, 85 and then every 8 weeks Phase I and phase IIa: 2) Arm A: days 1, 2, 5, 15, 16, 19 and 28. Arm B: days 1, 5, 9, 19 and 29. 3) Arm A: days -1, 5, 7, 14, 19 and 28. Arm B: days -1, 9, 11 and 19. 4) Arm A: days -1, 28, 43 and 85. Arm B: days -1, 5, 9, 29, 43 and 85. 5) Arm A: days 2 and 7. Arm B: days 2 and 9. | — |
Countries
Belgium, France, Spain, United States
Contacts
Public ContactMedical Affairs
TRANSGENE S.A.
Outcome results
None listed