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
Recruiting
PHASE1Ages 18+InterventionalTreatmentTelios Pharma, Inc.
~70 participants
Updated 2023-02-21 on ClinicalTrials.gov
What's tested:TL-895Ruxolitinib
At a glance
Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib
Measured over 28 days
+1 more outcome measured
Conditions
Where it's being run
19 sites across 8 statesFrance5
Spain4
Italy3
Ohio2
Germany2
Alabama1
Texas1
Poland1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib28 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 2424 Weeks
The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan.