TL-895 for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Primary Myelofibrosis+3 More
TL-895 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, TL-895, to see if it can help people with myelofibrosis who haven't responded well to other treatments.

Eligible Conditions
  • Primary Myelofibrosis
  • Post PV MF

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 48 Month

24 Weeks
Phase 1b - Spleen Volume Reduction (SVR) at Week 24
Phase 1b - TSS reduction at Week 24
Phase 2 - Spleen Volume Reduction (SVR) at Week 24
Phase 2 - TSS reduction at Week 24
28 days
Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib
48 Month
Progression Free Survival
48 Months
DOR Spleen
Overall Survival

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Phase 2 - Cohort 1 JAKi treatment-naïve MF
1 of 5
Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
1 of 5
Phase 1b - Dose Level 1
1 of 5
Phase 1b - Dose Level 2
1 of 5
Phase 1b - Dose Level 3
1 of 5

Experimental Treatment

70 Total Participants · 5 Treatment Groups

Primary Treatment: TL-895 · No Placebo Group · Phase 1 & 2

Phase 2 - Cohort 1 JAKi treatment-naïve MFExperimental Group · 2 Interventions: Ruxolitinib, TL-895 · Intervention Types: Drug, Drug
Phase 2 - Cohort 2 suboptimal response to RuxolitinibExperimental Group · 2 Interventions: Ruxolitinib, TL-895 · Intervention Types: Drug, Drug
Phase 1b - Dose Level 1Experimental Group · 2 Interventions: Ruxolitinib, TL-895 · Intervention Types: Drug, Drug
Phase 1b - Dose Level 2Experimental Group · 2 Interventions: Ruxolitinib, TL-895 · Intervention Types: Drug, Drug
Phase 1b - Dose Level 3Experimental Group · 2 Interventions: Ruxolitinib, TL-895 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~600
TL-895
2020
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 month

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be at least 18 years of age and able to provide informed consent.
You have adequate hematological, hepatic, & renal function.
You have a performance status of 0 to 2.
You have a high-risk, intermediate-2 risk, or intermediate-1 risk profile.
The spleen must be palpable or measured to be larger than 5 cm below the LLCM or larger than 450 cm3 by MRI or CT scan assessment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 23rd, 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.