Recruiting
Phase 1
Phase 2

TL-895 & Ruxolitinib

Sponsor:

Telios Pharma, Inc.

Code:

NCT05280509

Conditions

Myelofibrosis

Primary Myelofibrosis

Post-PV MF

Post-ET Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TL-895

Ruxolitinib

Study Details

Brief 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.

Conditions

Myelofibrosis

Primary Myelofibrosis

Post-PV MF

Post-ET Myelofibrosis

Study ID

NCT05280509

Start date

Jun 9, 2022

Status verified date

Feb, 2023

Completion date

Apr, 2027

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1b - Dose Level 1

150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

experimental: Phase 1b - Dose Level 2

300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

experimental: Phase 1b - Dose Level 3

450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

experimental: Phase 2 - Cohort 1 JAKi treatment-naïve MF

The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

The dose of ruxolitinib will be based on the subject's baseline platelet count.

experimental: Phase 2 - Cohort 2 suboptimal response to Ruxolitinib

The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.

Interventions

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.

Primary outcome measure

  • Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib [ Time Frame: 28 days ]
  • Phase 2 - Spleen Volume Reduction (SVR) at Week 24 [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@teliospharma.com

Nikki Stuart

nzona@teliospharma.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

University of Cincinnati (UC)

Recruiting

Cincinnati, Ohio, United States, 45267

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Telios Pharma, Inc.

Last update posted

Feb 21, 2023

Last verified

Feb, 2023

Keywords

  • Myelofibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Telios Pharma, Inc. on 2023-02-21.