A clinical study of TG6002 and flucytosine in patients with gastro-intestinal tumors

Phase 1

• Conditions: Gastro-intestinal cancer; MedDRA version: 21.1Level: PTClassification code 10053548Term: Gastrointestinal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000039-28-BE
• Lead Sponsor: TRANSGENE S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-05
• Study Completion: 2023-02-23
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

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

- Previous irradiation of target tumor
- MSI-High/dMMR colon cancer patients
- Glomerular filtration rate <60 mL/min/1.73m2 according to the Modification of Diet in Renal Diseases (MDRD) formula
- Immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or immunosuppressant agent, including systemic corticosteroids at a dose >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified