TL-895 for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Primary Myelofibrosis+1 More
TL-895 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat myelofibrosis, a bone marrow disorder. The drug is a pill that selectively targets an enzyme involved in the disease. The trial is for people who have not responded to other treatments.

Eligible Conditions
  • Primary Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Primary Myelofibrosis

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 44 months

44 months
Key Secondary Objective: To determine the duration of response (DOR).
Key Secondary Objective: To determine the duration overall response (OS).
Key Secondary Objective: To determine the progression-free survival (PFS).
9 months
Primary Objective, Part A: To determine the RP2D of TL-895 in each cohort.
Week 24
Key Secondary Objective: Improvement in Total Symptom Score at Week 24.
Primary Objective, Part B: To determine the SVR rate of Cohorts 1, 2, and 3 at Week 24.
Primary Objective, Part B: To determine the spleen volume reduction (SVR) rate at Week 24.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Primary Myelofibrosis

Trial Design

22 Treatment Groups

Cohort 3b, JAKi Ineligible Myelofibrosis
1 of 22
Arm 1b, Relapsed/Refractory Myelofibrosis
1 of 22
Arm 3a, JAKi Ineligible Myelofibrosis
1 of 22
Arm 2b, JAKi Intolerant Myelofibrosis
1 of 22
Cohort 1b, Relapsed/Refractory Myelofibrosis
1 of 22
Cohort 2a, JAKi Intolerant Myelofibrosis
1 of 22
Cohort 2b, JAKi Intolerant Myelofibrosis
1 of 22
Cohort 1 Expansion, Relapsed/Refractory Myelofibrosis
1 of 22
Cohort 3 Expansion, JAKi Ineligible Myelofibrosis
1 of 22
Cohort 1a, Relapsed/Refractory Myelofibrosis
1 of 22
Cohort 1c, Relapsed/Refractory Myelofibrosis
1 of 22
Cohort 1d, Relapsed/Refractory Myelofibrosis
1 of 22
Cohort 3a, JAKi Ineligible Myelofibrosis
1 of 22
Arm 1c, Relapsed/Refractory Myelofibrosis
1 of 22
Arm 3c, JAKi Ineligible Myelofibrosis
1 of 22
Arm 2 Expansion, JAKi Intolerant Myelofibrosis
1 of 22
Arm 1a, Relapsed/Refractory Myelofibrosis
1 of 22
Arm 2a, JAKi Intolerant Myelofibrosis
1 of 22
Arm 2c, JAKi Intolerant Myelofibrosis
1 of 22
Arm 1 Expansion, Relapsed/Refractory Myelofibrosis
1 of 22
Arm 3b, JAKi Ineligible Myelofibrosis
1 of 22
Arm 3 Expansion, JAKi Ineligible Myelofibrosis
1 of 22
Experimental Treatment

149 Total Participants · 22 Treatment Groups

Primary Treatment: TL-895 · No Placebo Group · Phase 2

Cohort 3b, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 1b, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 3a, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 2b, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 1b, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 2a, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 2b, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 1 Expansion, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 3 Expansion, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 1a, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 1c, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 1d, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Cohort 3a, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 1c, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 3c, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 2 Expansion, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 1a, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 2a, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 2c, JAKi Intolerant Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 1 Expansion, Relapsed/Refractory Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 3b, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Arm 3 Expansion, JAKi Ineligible Myelofibrosis
Drug
Experimental Group · 1 Intervention: TL-895 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TL-895
2020
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 44 months

Who is running the clinical trial?

Telios Pharma, Inc.Lead Sponsor
5 Previous Clinical Trials
343 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
186 Patients Enrolled for Primary Myelofibrosis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an adult (≥18 years of age) if you have a BMI of ≥25 kg/m.
You have a performance status of ≤2.
You have adequate hematologic, hepatic, and renal functions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.