drugset / Trial / NCT04195373
A Safety Study of TMV-018 in Patients With Tumors of the Gastrointestinal Tract
Phase 1
Withdrawn
Themis Bioscience GmbH
Assign Data Management and Biostatistics GmbH · collabOptimapharm · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-11-23
- Primary completion
- 2020-11-23
- Completion
- 2020-11-23
Outcome
Outcome not reported
Stopped (Enrollment): “Study not started, no subjects recruited.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flucytosine | Small molecule | 150 mg/kg | — |
| Subject | TMV-018 | Unknown | — | Other |