Clinical Trials Logo
  1. Home
  2. Gastrointestinal Cancer
  3. NCT04195373

A Safety Study of TMV-018 in Patients With Tumors of the Gastrointestinal Tract

Gastrointestinal Cancer Clinical Trial

Official title:
A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract

Clinical Trial Summary

This study aims to determine the safety and tolerability of TMV-018 when given alone or in combination with the prodrug 5-Fluorocytosine (5-FC) or an anti-PD-1 checkpoint inhibitor in patients with gastrointestinal tumors. Furthermore, the maximum tolerated dose (MTD) and recommended Phase II dose of TMV-018 shall be determined.

Clinical Trial Description

This is an open-label, multicenter, dose-escalation phase I trial that aims to determine the safety and tolerability of TMV-018, an oncolytic measles virus encoding the prodrug converting enzyme "super cytosine deaminase", when given alone or in combination with the prodrug 5-Fluorocytosine (5-FC) or an anti-PD-1 checkpoint inhibitor up to day 72 in patients with colorectal carcinoma (left-sided or rectal), esophageal carcinoma, or gastric cancer. Furthermore, the maximum tolerated dose (MTD) and recommended Phase II dose of TMV-018 shall be determined. At least 15 patients will be enrolled. Patients will be randomized to different treatment groups: all patients will receive intra-tumoral TMV-018 on four visits and additionally 5-FC and/or anti-PD-1 treatment. All adverse events will be documented and analyzed for the primary safety endpoint. Blood and tumor samples will be collected up to day 72 to determine the safety, tolerability and immunogenicity of the treatment. The patients will be followed-up for another two years to determine long-term safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04195373
Study type Interventional
Source Themis Bioscience GmbH
Contact
Status Withdrawn
Phase Phase 1
Start date November 23, 2020
Completion date November 23, 2020
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Not yet recruiting NCT05044312 - Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis N/A
Active, not recruiting NCT05053191 - Advancing Nursing Practices in Hospital Oncology Care N/A
Completed NCT03611309 - Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Withdrawn NCT04030624 - Remote Electronic Patient Monitoring in Gastrointestinal Cancer N/A
Completed NCT02140593 - The Laparotomy Study Phase 4
Completed NCT02222259 - A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients N/A
Active, not recruiting NCT00716209 - Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers N/A
Recruiting NCT01484444 - Biomarker Analysis of Gastrointestinal Cancer N/A
Completed NCT02130427 - A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy N/A
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00094965 - Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function Phase 2
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Recruiting NCT05226221 - Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Recruiting NCT03286348 - Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer N/A