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RecruitingPhase 1/Phase 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

Telios Pharma, Inc. · NCT05280509

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
70
US sites recruiting
4
Study start
June 9, 2022
Record last updated
February 21, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TL-895; Ruxolitinib

Conditions: Myelofibrosis; Primary Myelofibrosis; Post-PV MF; Post-ET Myelofibrosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • John Mei · 650-542-0136 · jmei@teliospharma.com
  • Nikki Stuart · nzona@teliospharma.com
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Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve… (NCT05280509) | Bored Studies