← Back to Search

Tyrosine Kinase Inhibitor

TL-895 for Myelofibrosis

Phase 2
Recruiting
Research Sponsored by Telios Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 44 months
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with Myelofibrosis who have a large spleen, are in fairly good health otherwise, and haven't responded well to or can't take JAK inhibitor treatments. They shouldn't have had certain other cancer treatments recently or any past spleen surgery.Check my eligibility
What is being tested?
The study tests TL-895, an oral drug designed to inhibit specific enzymes that may be involved in Myelofibrosis. It's aimed at patients whose disease has come back after treatment or who cannot tolerate current therapies.See study design
What are the potential side effects?
Potential side effects of TL-895 could include issues related to liver and kidney function, blood disorders due to bone marrow suppression, gastrointestinal symptoms, fatigue, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spleen is enlarged, extending 5 cm below my ribcage or is larger than 450 cm³ on scans.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been diagnosed with a type of myelofibrosis according to WHO criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Objective, Part A: To determine the RP2D of TL-895 in each cohort.
Primary Objective, Part B: To determine the spleen volume reduction (SVR) rate at Week 24.
Secondary outcome measures
Key Secondary Objective: Improvement in Total Symptom Score at Week 24.
Key Secondary Objective: To determine the duration of response (DOR).
Key Secondary Objective: To determine the duration overall response (OS).
+1 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort 3b, JAKi Ineligible MyelofibrosisExperimental Treatment1 Intervention
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Group II: Cohort 3a, JAKi Ineligible MyelofibrosisExperimental Treatment1 Intervention
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Group III: Cohort 3 Expansion, JAKi Ineligible MyelofibrosisExperimental Treatment1 Intervention
TL-895 administered orally at RP2D and schedule
Group IV: Cohort 2b, JAKi Intolerant MyelofibrosisExperimental Treatment1 Intervention
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Group V: Cohort 2a, JAKi Intolerant MyelofibrosisExperimental Treatment1 Intervention
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Group VI: Cohort 1d, Relapsed/Refractory MyelofibrosisExperimental Treatment1 Intervention
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Group VII: Cohort 1c, Relapsed/Refractory MyelofibrosisExperimental Treatment1 Intervention
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Group VIII: Cohort 1b, Relapsed/Refractory MyelofibrosisExperimental Treatment1 Intervention
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Group IX: Cohort 1a, Relapsed/Refractory MyelofibrosisExperimental Treatment1 Intervention
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Group X: Cohort 1 Expansion, Relapsed/Refractory MyelofibrosisExperimental Treatment1 Intervention
TL-895 administered orally at RP2D and schedule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TL-895
2020
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Telios Pharma, Inc.Lead Sponsor
9 Previous Clinical Trials
1,258 Total Patients Enrolled

Media Library

TL-895 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04655118 — Phase 2
Myelofibrosis Research Study Groups: Cohort 1d, Relapsed/Refractory Myelofibrosis, Cohort 1a, Relapsed/Refractory Myelofibrosis, Cohort 1b, Relapsed/Refractory Myelofibrosis, Cohort 1c, Relapsed/Refractory Myelofibrosis, Cohort 2a, JAKi Intolerant Myelofibrosis, Cohort 2b, JAKi Intolerant Myelofibrosis, Cohort 3a, JAKi Ineligible Myelofibrosis, Cohort 3b, JAKi Ineligible Myelofibrosis, Cohort 1 Expansion, Relapsed/Refractory Myelofibrosis, Cohort 3 Expansion, JAKi Ineligible Myelofibrosis
Myelofibrosis Clinical Trial 2023: TL-895 Highlights & Side Effects. Trial Name: NCT04655118 — Phase 2
TL-895 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04655118 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment ongoing for this research endeavor?

"According to clinicaltrials.gov, this research study is in need of participants. It was first announced on October 22nd 2020 and the latest update happened on October 11th 2022."

Answered by AI

How many locations have this research project been implemented in?

"The current clinical trial has 8 study sites, situated in Baltimore, Canton, Columbus and 5 other cities. To minimize travel demands while taking part in the research project it is beneficial to select a site close by."

Answered by AI

How many individuals have been included in the enrollment process of this clinical trial?

"In order to launch the trial, 149 suitable participants must be recruited. Telios Pharma, Inc., has chosen two sites as their base of operations- University of Maryland in Baltimore and Gabrail Cancer Center close by Canton, Ohio."

Answered by AI

Has the regulatory agency given their stamp of approval to TL-895?

"In comparison to other treatments, TL-895's safety is estimated at a 2 because there has not been any evidence of its efficacy yet. However, the data that does exist suggests its safety is satisfactory."

Answered by AI

What goals has this analysis been designed to achieve?

"The primary aim of this scientific experiment, to be evaluated after 24 weeks, is to determine the recommended phase 2 dose (RP2D) for TL-895 in each cohort. Secondary objectives include a 50% reduction in total symptom score at week 24 according to MFSAF v4.0., progression-free survival from first dose until either disease progression or death from any cause and duration of response calculated as time between initial response and eventual relapse."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TL-895 in Subjects With Myelofibrosis
2020. "Study of TL-895 in Subjects With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655118.
All > Myelofibrosis
~33 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top