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Clinical Trials in Spain / NCT05280509
Recruiting Phase 1/2

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

NCT05280509 · tracked via the Priya Life Science Spain tracker
Sponsor
Telios Pharma, Inc
Phase
Phase 1/2
Started
2022-06-09
Last updated
2023-02-21

Condition(s) studied

MyelofibrosisPrimary MyelofibrosisPost-PV MFPost-ET Myelofibrosis

Investigational drug(s) / intervention(s)

TL-895Ruxolitinib →

TL-895: TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.

Ruxolitinib: Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib — 28 days
    Dose-limiting toxicities (DLTs) will be used to establish the maximum-tolerated dose (MTD) of TL-895 in combination with ruxolitinib. The safety review committee (SRC) will determine the RP2D based on safety and efficacy data of the combination of TL-895 and ruxolitinib.
  • Phase 2 - Spleen Volume Reduction (SVR) at Week 24 — 24 Weeks
    The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan.

Trial sites (19)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Gabrail Cancer Center Canton Ohio Recruiting
University of Cincinnati (UC) Cincinnati Ohio Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
CHU Angers Angers France Recruiting
AP-HM - Hôpital de la Timone Marseille France Recruiting
CHU de Nice - Hopital L'Archet II Nice France Recruiting
Hôpital Saint Louis - AP-HP Paris France Recruiting
Centre Hospitalier Lyon Sud Pierre-Bénite France Recruiting
Marien Hospital Duesseldorf Düsseldorf Germany Recruiting
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall Halle Germany Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Bologna Italy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milan Italy Recruiting
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia Perugia Italy Recruiting
Pratia Onkologia Katowice Katowice Poland Recruiting
Hospital Universitari Arnau de Vilanova Lleida Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Universitario Virgen de la Victoria Málaga Spain Recruiting
Hospital Quironsalud de Zaragoza Zaragoza Spain Recruiting

On this site

📄 Jakafi (ruxolitinib) drug profile →

Other trials for the same condition

A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis Active, not recruiting
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis Active, not recruiting
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib Recruiting
Clinical Epidemiology in Contemporary Patients With Myelofibrosis. Recruiting
A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05280509 on ClinicalTrials.gov ↗ ← All trials in Spain