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NCT Number: NCT05280509

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.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Post-ET Myelofibrosis Post-PV MF Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TL-895

Drug

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

Ruxolitinib

Drug

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

Other names: Jakafi, Jakavi

Primary outcomes

  1. Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib

    Time frame: 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.

  2. Phase 2 - Spleen Volume Reduction (SVR) at Week 24

    Time frame: 24 Weeks

    The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan.

Secondary outcomes

  1. Phase 1b - Spleen Volume Reduction (SVR) at Week 24

    Time frame: 24 Weeks

    The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan.

  2. Phase 1b - TSS reduction at Week 24

    Time frame: 24 Weeks

    The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.

  3. Phase 2 - TSS reduction at Week 24

    Time frame: 24 Weeks

    The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by MFSAF v4.0.

  4. DOR Spleen

    Time frame: 48 Months

    Time from initial SVR of ≥ 35% by MRI/CT until the first occurrence of disease progression or death

  5. Progression Free Survival

    Time frame: 48 Month

    Time from first dose to progression or death from any cause.

  6. Overall Survival

    Time frame: 48 Months

    Time from first dose to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

John Mei

CONTACT

[email protected]

650-542-0136

Nikki Stuart

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Telios Pharma, Inc.

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Mar 15, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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