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NCT05280509 · ClinicalTrials.gov registry record · Phase 1

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

A Phase 1 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Telios Pharma.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
19
Study locations

NCT05280509 is a Phase 1 study of Myelofibrosis and Primary Myelofibrosis that is actively recruiting participants, run by Telios Pharma. The registered enrollment target is 70 participants, below the 195-participant average among 61 other Myelofibrosis trials with a reported enrollment target (64% lower). The trial reports 19 study locations across 4 states.

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The verdict

NCT05280509, a Phase 1 study of Myelofibrosis and Primary Myelofibrosis, is actively recruiting participants, sponsored by Telios Pharma.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
19
Study locations

Study Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

Conditions Studied

Myelofibrosis Primary Myelofibrosis Post-PV MF Post-ET Myelofibrosis

Interventions

  • DRUG Ruxolitinib
  • DRUG TL-895

Study Locations (19)

Other

  • CHU Angers - Angers
  • AP-HM - Hôpital de la Timone - Marseille
  • CHU de Nice - Hopital L'Archet II - Nice
  • Hôpital Saint Louis - AP-HP - Paris
  • Centre Hospitalier Lyon Sud - Pierre-Bénite
  • Marien Hospital Duesseldorf - Düsseldorf
  • Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall - Halle
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola - Bologna
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano - Milan
  • Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia - Perugia
  • Pratia Onkologia Katowice - Katowice
  • Hospital Universitari Arnau de Vilanova - Lleida
  • Hospital Universitario Ramon y Cajal - Madrid
  • Hospital Universitario Virgen de la Victoria - Málaga
  • Hospital Quironsalud de Zaragoza - Zaragoza

Ohio

  • Gabrail Cancer Center - Canton
  • University of Cincinnati (UC) - Cincinnati

Alabama

  • University of Alabama at Birmingham - Birmingham

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-06-09
Est. Completion 2027-04
Phase Phase 1

Sponsor

Telios Pharma

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05280509

The ClinicalTrials.gov registry entry for NCT05280509 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 61 other Myelofibrosis trials with a reported enrollment target (64% lower). The listed sponsor is Telios Pharma, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.

NCT05280509 reports 19 study locations spanning 4 distinct geographic areas - top geographies include Other, Ohio, Alabama.

Frequently Asked Questions

What is clinical trial NCT05280509 about?

NCT05280509 is a clinical study titled "Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib". This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

What is the current status of trial NCT05280509?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2022-06-09. Estimated completion is 2027-04.

What conditions does trial NCT05280509 study?

This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis.

What interventions are being tested in trial NCT05280509?

The interventions under investigation include: Ruxolitinib (DRUG), TL-895 (DRUG).

Who is sponsoring clinical trial NCT05280509?

This trial is sponsored by Telios Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05280509 being conducted?

This trial has 19 study locations across Alabama, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.