Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Last updated: May 8, 2024
Sponsor: Telios Pharma, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Warts

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Treatment

Placebo

TL-895

Clinical Study ID

NCT04655118
TL-895-201
  • Ages > 18
  • All Genders

Study Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Eligibility Criteria

Inclusion

Cohorts 1-3 Key Inclusion Criteria:

  • Adults ≥18 years of age
  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treatingphysician according to the World Health Organization (WHO) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Adequate hematologic, hepatic, and renal functions
  • MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
  • Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50x 10^9/L

Exclusion

Key Exclusion Criteria:

  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with JAKi within 28 days prior to study treatment
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of studytreatment Cohort 5 Key Inclusion Criteria:
  • Adults ≥18 years of age
  • Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review ofbone marrow biopsy pathology report results
  • Subject must have moderate-to-severe symptoms Key Exclusion Criteria:
  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
  • Diagnosis with another myeloproliferative disorder

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 22, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Border Medical Oncology

    East Albury,
    Australia

    Completed

  • Southern Oncology Specialists

    Kogarah, 2217
    Australia

    Completed

  • South Eastern Private Hospital

    Noble Park,
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, 6000
    Australia

    Active - Recruiting

  • St Vincent's Hospital Sydney

    Sydney, 2010
    Australia

    Active - Recruiting

  • Chu De Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200
    Belgium

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035
    Brazil

    Site Not Available

  • Hematologista e Pesquisadora Clínica Hospital A Beneficência Portugues

    São Paulo, 01323
    Brazil

    Active - Recruiting

  • Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas

    São Paulo, 76805
    Brazil

    Completed

  • Universidade de Sao Paulo - Hospital das Clinicas da Faculdade de Medicina

    São Paulo, 05403
    Brazil

    Active - Recruiting

  • Dr. Georgi Stranski University Hospital

    Pleven, 5809
    Bulgaria

    Site Not Available

  • Military Medical Academy

    Sofia,
    Bulgaria

    Site Not Available

  • National Specialized Hospital for Active Treatment of Hematological Diseases

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • University Hospital "St Ivan Rilski"

    Sofia, 1431
    Bulgaria

    Completed

  • CHRU de Brest - Hôpital Morvan

    Brest, 29200
    France

    Site Not Available

  • CH Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44000
    France

    Completed

  • CHU de Nice - Hopital L' Archet II

    Nice, 06200
    France

    Completed

  • Hôpital Saint-Louis AP-HP

    Paris, 75010
    France

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Marien Hospital Duesseldorf

    Düsseldorf, 40479
    Germany

    Completed

  • Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall

    Halle, 07747
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena, 07743
    Germany

    Active - Recruiting

  • Praxisklinik fur Hamatologie und Onkologie

    Koblenz, 56073
    Germany

    Completed

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Completed

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300
    Hungary

    Completed

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400
    Hungary

    Site Not Available

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete

    Nyíregyháza, 4400
    Hungary

    Completed

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000
    Hungary

    Completed

  • S. Orsola-Malpighi Polyclinic

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

    Catania, 95123
    Italy

    Site Not Available

  • Presidio Ospedaliero Gaspare Rodolico

    Catania, 95125
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola, 47014
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore Della Carita'

    Novara, 28100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia

    Perugia, 06129
    Italy

    Site Not Available

  • AUSL della Romagna-Ospedale S.Maria delle Croci

    Ravenna, 48121
    Italy

    Site Not Available

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli

    Reggio Calabria, 89124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • Ospedale dell'Angelo

    Venezia, 30174
    Italy

    Site Not Available

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Completed

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Completed

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul,
    Korea, Republic of

    Completed

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdańsk, 80-211
    Poland

    Site Not Available

  • Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego

    Kraków, 31-501
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

    Wrocław, 52-007
    Poland

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Salamanca University Hospital

    Salamanca, 37007
    Spain

    Completed

  • Hospital Quirónsalud Zaragoza

    Zaragoza, 50006
    Spain

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City,
    Taiwan

    Completed

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Completed

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Completed

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado 80045
    United States

    Completed

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Revive Research Institute - Royal Oak

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Revive Research Institute - Sterling Heights

    Sterling Heights, Michigan 48126
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Completed

  • University of Cincinnati (UC) Physicians Company, LLC

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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