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

NCT04195373 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-11-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TMV-018 + 5-FC

TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme "super cytosine deaminase"; 1E+06 TCID50 to 1E+08 TCID50 per dose. 5-FC: 150 mg/kg/day for 2 days during each treatment.

BIOLOGICAL

TMV-018 + anti-PD-1

TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme "super cytosine deaminase"; 1E+06 TCID50 to 1E+08 TCID50 per dose. Anti-PD-1 inhibitor dose according to its SMPC.

BIOLOGICAL

TMV-018 + 5-FC + anti-PD-1

TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme "super cytosine deaminase"; 1E+06 TCID50 to 1E+08 TCID50 per dose. 5-FC: 150 mg/kg/day for 2 days during each treatment cycle. Anti-PD-1 Inhibitor: dose according to its SMPC.

Sponsors & Collaborators

  • Assign Data Management and Biostatistics GmbH

    collaborator OTHER

  • Optimapharm

    collaborator INDUSTRY

  • Themis Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Ulrich Lauer, MD · University Hospital Tuebingen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2020-11-23
Completion
2020-11-23

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195373 on ClinicalTrials.gov