EUCTR2018-000039-28-BE进行中（未招募）1 期
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 - TG6002.02
TRANSGENE S.A.0 个研究点目标入组 51 人开始时间: 2018年4月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
研究者
相似试验
进行中（未招募）
1 期
A clinical study of TG6002 and flucytosine in patients with gastro-intestinal tumorsGastro-intestinal cancerMedDRA version: 20.0Level: PTClassification code 10053548Term: Gastrointestinal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000039-28-FRTRANSGENE S.A.59
进行中（未招募）
1 期
A clinical study of TG6002 and flucytosine in patients with gastro-intestinal tumorsGastro-intestinal cancerMedDRA version: 20.0Level: PTClassification code 10053548Term: Gastrointestinal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000039-28-ESTRANSGENE S.A.59
终止
1 期
Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors.Colorectal NeoplasmDigestive System NeoplasmNCT03724071Transgene51
进行中（未招募）
1 期
A clinical trial of a new drug known as Ti-061, that will take place in patients with tumors. Ti-061 will be assessed as a standalone drug as well as being assessed when taken with another drug, called Pembrolizumab.Advanced malignanciesMedDRA version: 19.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10066476Term: Haematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004372-22-GBTioma Therapeutics, Inc.320
终止
1 期
Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal CancerColorectal NeoplasmsNCT04194034Transgene15