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

ConditionsMyelofibrosisPrimary MyelofibrosisPost-PV MFPost-ET Myelofibrosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelios Pharma, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Prior treatment with any JAKi

Documented disease progression while on ruxolitinib treatment

Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Prior treatment with a BTK or BMX inhibitor

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 5 treatment groups
Group A: Phase 1b - Dose Level 1Experimental treatment 2 interventions
Group B: Phase 1b - Dose Level 2Experimental treatment 2 interventions
Group C: Phase 1b - Dose Level 3Experimental treatment 2 interventions
Group D: Phase 2 - Cohort 1 JAKi treatment-naïve MFExperimental treatment 2 interventions
Group E: Phase 2 - Cohort 2 suboptimal response to RuxolitinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
28 days
2

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

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

Time frame
24 Weeks

Secondary outcomes

1

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

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

Time frame
24 Weeks
2

Phase 1b - TSS reduction at Week 24

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

Time frame
24 Weeks
3

Phase 2 - TSS reduction at Week 24

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

Time frame
24 Weeks
4

DOR Spleen

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

Time frame
48 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Telios Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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