TL-895 with SOC vs SOC treatment of COVID-19 in patients with cancer
Research type
Research Study
Full title
A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 with Standard Available Treatment versus Standard Available Treatment for the Treatment of COVID-19 in Patients with Cancer
IRAS ID
285613
Contact name
Jacqueline Pugh
Contact email
Sponsor organisation
Telios Pharma, Inc.
Eudract number
2020-002259-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
148568, IND Number
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The purpose of this study is to determine if TL-895 is well-tolerated and whether it is an effective treatment to prevent the need for ventilators in hospitalised cancer patients with coronavirus disease 2019 (COVID-19). This phase 1/2 study will evaluate TL-895 with standard available COVID-19 treatment compared to standard available COVID-19 treatment alone.
TL-895, is a tyrosine kinase inhibitor. “Kinases” are a part of many cell processes, including in the immune system. The kinase blocked by TL-895 is believed to help decrease lung inflammation, while not affecting the body’s natural defence against the COVID-19 virus. TL-895 may be able to improve functions of the natural defense cells against the COVID-19 virus, and reduce the need to use ventilators.
Part 1 is being done to find the best dose of TL-895 to be used in Part 2. TL-895 will be taken twice a day in 7-day cycles for 2 cycles. If appropriate, the study doctor may give an additional 2 cycles, for up to 4 cycles.
Part 2 will start after Part 1 is completed. In Part 2, participants will be randomly assigned to take TL-895 or placebo alongside the available treatment of COVID-19. Part 2 of the study is double-blinded, so neither the study doctor nor participant, nor Sponsor, will know to which arm the participant was randomised. The Part 2 dose will be the recommended dose from Part 1. The study treatment is taken in 7-day cycles for 2 cycles (14 days). Depending on the participants condition after completion of the 2 cycles, the study doctor may give an additional 2 cycles; for up to 4 cycles. It is expected that participants will be in the study for a total of approximately 4 months.
Globally, up to approximately 146 participants will participate in this study.REC name
London - Riverside Research Ethics Committee
REC reference
20/HRA/3280
Date of REC Opinion
13 Jul 2020
REC opinion
Unfavourable Opinion