Recruiting
Phase 2

TL-895

Sponsor:

Telios Pharma, Inc.

Code:

NCT04655118

Conditions

Myelofibrosis

Indolent Systemic Mastocytosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TL-895

Placebo

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 (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Conditions

Myelofibrosis

Indolent Systemic Mastocytosis

Study ID

NCT04655118

Start date

Oct 22, 2020

Status verified date

May, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Cohorts 1-3

Key Inclusion Criteria:

  • Adults ≥18 years of age
  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Adequate hematologic, hepatic, and renal functions
  • MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
  • Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10\^9/L

Key Exclusion Criteria:

  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with JAKi within 28 days prior to study treatment
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Cohort 5

Key Inclusion Criteria:

  • Adults ≥18 years of age
  • Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
  • Subject must have moderate-to-severe symptoms

Key Exclusion Criteria:

  • Prior treatment with any BTK or BMX inhibitors
  • Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
  • Diagnosis with another myeloproliferative disorder

Study Design

Enrollment

121 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1a, Relapsed/Refractory Myelofibrosis

150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 1b, Relapsed/Refractory Myelofibrosis

300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 1c, Relapsed/Refractory Myelofibrosis

300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 1d, Relapsed/Refractory Myelofibrosis

450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 2a, JAKi Intolerant Myelofibrosis

150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 2b, JAKi Intolerant Myelofibrosis

300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L

150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L

300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

experimental: Cohort 5a, Indolent Systemic Mastocytosis

TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC).

experimental: Cohort 5b, Indolent Systemic Mastocytosis

TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

experimental: Cohort 5c, Indolent Systemic Mastocytosis

TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

experimental: Cohort 5d, Indolent Systemic Mastocytosis

TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

placebo comparator: Cohort 5e, Indolent Systemic Mastocytosis

Placebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

Interventions

TL-895

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

Placebo

Placebo to match TL-895

Primary outcome measure

  • Cohorts 1-3: Determine the RP2D of TL-895 [ Time Frame: 9 months ]
  • Cohort 5: Determine the RP2D of TL-895 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@teliospharma.com

Emily Houlihan

401-954-8042ehoulihan@teliospharma.com

Locations

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

University of Texas, MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Telios Pharma, Inc.

Last update posted

May 10, 2024

Last verified

May, 2024

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 2024-05-10.