A clinical study of TG6002 and flucytosine in patients with colorectal cancer

A dose escalation and phase IIa study of TG6002 plus flucytosine in patients with unresectable colorectal cancer with liver metastases

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004103-39-GB

Enrollment

Registered

2019-04-02

Start date

2019-10-25

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: VV TK-RR-FCU1 Product Code: TG6002 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not applicable Current Sponsor code: TG6002 Other descriptive name: VV TK-RR-FCU1 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological or cytological diagnosis of colorectal cancer. 2. Unresectable metastatic colorectal cancer with at least one measurable liver metastasis. 3. At least one liver metastasis amenable to biopsy. 4. Patients previously exposed to fluoropyrimidine-based chemotherapy. 5. (Phase I) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy, or patients on or entering a period of clinical observation without treatment. 6. (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Predominant extrahepatic disease. 2. Symptomatic brain metastases or meningeal tumors. 3. Documented occlusion of the hepatic artery or main portal vein. 4. Reverse portal vein flow on ultrasound sonography. 5. Any contraindication to intrahepatic artery infusion procedure including portosystemic shunt, and artery occlusive disease (ceoliac trunk and/or superior mesenteric artery), if it may inhibit catheterization of the hepatic artery. 6. 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
Secondary Objective: Phase I: 1. Safety 2. Efficacy 3. TG6002 in urine, saliva and faeces 4. TG6002 in blood 5. 5-FC, 5-FU and FBAL in serum 6. TG6002 in tumor 7. 5-FC, 5-FU and FBAL in tumor Phase IIa: 1. Safety 2. Efficacy with other endpoints 3. TG6002 in blood 4. 5-FC, 5-FU and FBAL in serum 5. TG6002 in tumor 6. 5-FC, 5-FU and FBAL in tumor;Main Objective: Phase I: Determination of the maximum tolerated dose (MTD) or maximum feasible dose (MFD) and the recommended dose for the Phase IIa part (RP2D). Phase IIa: Determination of the preliminary efficacy of intrahepatic artery injection of TG6002 in combination with 5-FC.;Primary end point(s): Phase I: Dose-limiting toxicities, adverse events, serious adverse events, change in standard laboratory parameters and vital signs. Phase IIa: Disease control rate (DCR).;Timepoint(s) of evaluation of this end point: Phase I: Days 1, 2, 4, 8, 15 and 29. Phase IIa: Ten (10) weeks from the first intrahepatic artery TG6002 injection.	—

Measure

Time frame

Secondary Objective: Phase I: 1. Safety 2. Efficacy 3. TG6002 in urine, saliva and faeces 4. TG6002 in blood 5. 5-FC, 5-FU and FBAL in serum 6. TG6002 in tumor 7. 5-FC, 5-FU and FBAL in tumor Phase IIa: 1. Safety 2. Efficacy with other endpoints 3. TG6002 in blood 4. 5-FC, 5-FU and FBAL in serum 5. TG6002 in tumor 6. 5-FC, 5-FU and FBAL in tumor;Main Objective: Phase I: Determination of the maximum tolerated dose (MTD) or maximum feasible dose (MFD) and the recommended dose for the Phase IIa part (RP2D). Phase IIa: Determination of the preliminary efficacy of intrahepatic artery injection of TG6002 in combination with 5-FC.;Primary end point(s): Phase I: Dose-limiting toxicities, adverse events, serious adverse events, change in standard laboratory parameters and vital signs. Phase IIa: Disease control rate (DCR).;Timepoint(s) of evaluation of this end point: Phase I: Days 1, 2, 4, 8, 15 and 29. Phase IIa: Ten (10) weeks from the first intrahepatic artery TG6002 injection.

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Secondary

Measure	Time frame
Secondary end point(s): Phase I: 1. Adverse events, serious adverse events, change in standard laboratory parameters and vital signs. 2. DCR. 3. Quantification of viral particles in urine, saliva and faeces. 4. Quantification of viral particles in blood. 5. Concentration of 5-FC, 5-FU and FBAL in serum. 6. Quantification of viral particles in tumor. 7. Concentration of 5-FC, 5-FU and FBAL in tumor. Phase IIa: 1. Adverse events, serious adverse events, change in standard laboratory parameters and vital signs. 2. Overall response rate (ORR), duration of response (DoR), progression-free survival (PFS), sum of longest diameters (SLD) of target lesions and overall survival (OS). 3. Quantification of viral particles in blood. 4. Concentration of 5-FC, 5-FU and FBAL in serum. 5. Quantification of viral particles in tumor. 6. Concentration of 5-FC, 5-FU and FBAL in tumor. ;Timepoint(s) of evaluation of this end point: Phase I: 1. Days 1, 2, 4, 8, 15, 29, 43, 44, 46, 50, 57, 71, 85 and every 8 weeks thereafter. 2. Ten (10) weeks from the first intrahepatic artery TG6002 injection. 3. Days 2 and 8. 4. Days 1, 2, 4 or 8, 43 and 44. 5. Days 8 and 50. 6. Day 4 or 8. 7. Day 4 or 8. Phase IIa: 1. Days 1, 2, 4, 8, 15, 29, 43, 44, 46, 50, 57, 71, 85 and every 8 weeks thereafter. 2. Days 29 and 71 and every 8 weeks thereafter. 3. Days 1, 2, 4 or 8, 43 and 44. 4. Days 8 and 50. 5. Day 4 or 8. 6. Day 4 or 8.	—

Measure

Time frame

Secondary end point(s): Phase I: 1. Adverse events, serious adverse events, change in standard laboratory parameters and vital signs. 2. DCR. 3. Quantification of viral particles in urine, saliva and faeces. 4. Quantification of viral particles in blood. 5. Concentration of 5-FC, 5-FU and FBAL in serum. 6. Quantification of viral particles in tumor. 7. Concentration of 5-FC, 5-FU and FBAL in tumor. Phase IIa: 1. Adverse events, serious adverse events, change in standard laboratory parameters and vital signs. 2. Overall response rate (ORR), duration of response (DoR), progression-free survival (PFS), sum of longest diameters (SLD) of target lesions and overall survival (OS). 3. Quantification of viral particles in blood. 4. Concentration of 5-FC, 5-FU and FBAL in serum. 5. Quantification of viral particles in tumor. 6. Concentration of 5-FC, 5-FU and FBAL in tumor. ;Timepoint(s) of evaluation of this end point: Phase I: 1. Days 1, 2, 4, 8, 15, 29, 43, 44, 46, 50, 57, 71, 85 and every 8 weeks thereafter. 2. Ten (10) weeks from the first intrahepatic artery TG6002 injection. 3. Days 2 and 8. 4. Days 1, 2, 4 or 8, 43 and 44. 5. Days 8 and 50. 6. Day 4 or 8. 7. Day 4 or 8. Phase IIa: 1. Days 1, 2, 4, 8, 15, 29, 43, 44, 46, 50, 57, 71, 85 and every 8 weeks thereafter. 2. Days 29 and 71 and every 8 weeks thereafter. 3. Days 1, 2, 4 or 8, 43 and 44. 4. Days 8 and 50. 5. Day 4 or 8. 6. Day 4 or 8.

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Countries

United Kingdom

Contacts

Public ContactMedical Affairs

TRANSGENE S.A.

clinical.trials@transgene.fr33388279155

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026