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NCT05280509PHASE1, PHASE2Recruiting

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

Telios Pharma, Inc.

Start Date

6/9/2022

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Subjects with suboptimal response to ruxolitinib: * Treatment with at a stable dose of ruxolitinib prior to study entry * Subjects ≥ 18 years of age and able to provide informed consent. * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria * High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS) * Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate hematological, hepatic, \& renal function. Exclusion Criteria: Treatment-naive subjects: * Prior treatment with any JAKi Subjects with suboptimal response to ruxolitinib: * Documented disease progression while on ruxolitinib treatment All subjects: * Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment * Prior treatment with a BTK or BMX inhibitor

Interventions

DRUG

TL-895

DRUG

Ruxolitinib

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Conditions

MyelofibrosisPrimary MyelofibrosisPost-PV MFPost-ET Myelofibrosis

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

University of Cincinnati (UC)

Cincinnati, Ohio 45267

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

CHU Angers

Angers, 49100

France

AP-HM - Hôpital de la Timone

Marseille, 13005

France

CHU de Nice - Hopital L'Archet II

Nice, 06200

France

Hôpital Saint Louis - AP-HP

Paris, 75010

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495

France

Marien Hospital Duesseldorf

Düsseldorf, 40479

Germany

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

Halle, 40479

Germany

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, 40138

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122

Italy

Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia

Perugia, 06129

Italy

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Hospital Universitari Arnau de Vilanova

Lleida, 25198

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Quironsalud de Zaragoza

Zaragoza, 50006

Spain