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Trial record 1 of 1 for:    TL-895-201
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Study of TL-895 in Subjects With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655118
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Telios Pharma, Inc.

Study Description
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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 be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

Condition or disease Intervention/treatment Phase
Myelofibrosis Drug: TL-895 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
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.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Experimental: Cohort 3a, JAKi Ineligible Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Experimental: Cohort 3b, JAKi Ineligible Myelofibrosis
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Experimental: Cohort 1 Expansion, Relapsed/Refractory Myelofibrosis
TL-895 administered orally at RP2D and schedule
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Experimental: Cohort 3 Expansion, JAKi Ineligible Myelofibrosis
TL-895 administered orally at RP2D and schedule
 Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Objective, Part A: To determine the RP2D of TL-895 in each cohort. [ Time Frame: 9 months ]
    The safety review committee (SRC) will determine the RP2D for Cohorts 1, 2 and 3 based on safety and tolerability data obtained from each arm of that cohort.

  2. Primary Objective, Part B: To determine the spleen volume reduction (SVR) rate at Week 24. [ Time Frame: Week 24 ]
    The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan (central review).


Secondary Outcome Measures :
  1. Key Secondary Objective: Improvement in Total Symptom Score at Week 24. [ Time Frame: Week 24 ]
    The proportion of subjects achieving ≥50% reduction in Total Symptom Score at Week 24 by MFSAF v4.0.

  2. Key Secondary Objective: To determine the duration of response (DOR). [ Time Frame: 44 months ]
    Time from initial response to progression.

  3. Key Secondary Objective: To determine the progression-free survival (PFS). [ Time Frame: 44 months ]
    Time from the first dose to progression or death from any cause.

  4. Key Secondary Objective: To determine the duration overall response (OS). [ Time Frame: 44 months ]
    Time from the first dose to death of any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm³ by MRI or CT scan assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

  • Prior treatment with any BTK or BMX inhibitors
  • Cohorts 1 and 2 - Prior treatment with JAKi within 21 days of the Screening MRI/CT scan. Subjects in Cohort 3 must not have received JAKi
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655118


Contacts
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Contact: John Mei 650-542-0136 jmei@teliospharma.com
Contact: Sherry Toney SToney@teliospharma.com

Locations
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Sponsors and Collaborators
Telios Pharma, Inc.
More Information
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Responsible Party: Telios Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04655118    
Other Study ID Numbers: TL-895-201
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases