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Tyrosine Kinase Inhibitor

TL-895 + Ruxolitinib for Myelofibrosis

Phase 1 & 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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 month

Awards & highlights

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.

Who is the study for?

This trial is for adults with Myelofibrosis (MF) who are either new to JAK inhibitor treatments or haven't responded well to Ruxolitinib. They should have a confirmed MF diagnosis, a spleen enlarged by at least 5 cm or of a certain volume, and be in fair health as judged by their ability to perform daily activities.Check my eligibility

What is being tested?

The study tests TL-895 combined with Ruxolitinib on two groups: those who've never had JAK inhibitors and those whose condition didn't improve enough with just Ruxolitinib. It aims to see if this combination can better manage symptoms of MF.See study design

What are the potential side effects?

Potential side effects include issues that affect blood cell counts, liver and kidney function. Since the drugs target specific enzymes in the body, there might also be unexpected reactions related to these pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My condition is classified as high, intermediate-2, or intermediate-1 risk.

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My spleen is enlarged, extending 5 cm below my ribcage or is larger than 450 cm3 on a scan.

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I have been diagnosed with a type of myelofibrosis according to WHO criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib

Phase 2 - Spleen Volume Reduction (SVR) at Week 24

Secondary outcome measures

DOR Spleen

Overall Survival

Phase 1b - Spleen Volume Reduction (SVR) at Week 24

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase 2 - Cohort 2 suboptimal response to RuxolitinibExperimental Treatment2 Interventions

The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.

Group II: Phase 2 - Cohort 1 JAKi treatment-naïve MFExperimental Treatment2 Interventions

The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose of ruxolitinib will be based on the subject's baseline platelet count.

Group III: Phase 1b - Dose Level 3Experimental Treatment2 Interventions

450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

Group IV: Phase 1b - Dose Level 2Experimental Treatment2 Interventions

300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

Group V: Phase 1b - Dose Level 1Experimental Treatment2 Interventions

150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TL-895

2020

Completed Phase 1

~10

Ruxolitinib

2018

Completed Phase 3

~1140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Telios Pharma, Inc.Lead Sponsor

9 Previous Clinical Trials

1,337 Total Patients Enrolled

Media Library

Ruxolitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05280509 — Phase 1 & 2

Myelofibrosis Research Study Groups: Phase 1b - Dose Level 3, Phase 2 - Cohort 1 JAKi treatment-naïve MF, Phase 1b - Dose Level 1, Phase 1b - Dose Level 2, Phase 2 - Cohort 2 suboptimal response to Ruxolitinib

Myelofibrosis Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT05280509 — Phase 1 & 2

Ruxolitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280509 — Phase 1 & 2

Frequently Asked Questions

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

What is the aggregate number of participants involved in this trial?

"Indeed, the information on clinicaltrials.gov confirms that this medical trial is currently recruiting participants. After being initially posted on October 1st 2022, it was most recently updated on November 10th 2022 and seeks 70 individuals from one clinic site."

Answered by AI

What aims is this research endeavor attempting to accomplish?

"According to Telios Pharma, Inc., the primary outcome of this 24-week medical trial will be determining a recommended Phase 2 dose for TL-895 in combination with ruxolitinib. Secondary outcomes include assessing TSS reduction at Week 24 by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0, evaluating Disease Response Spleen (DOR Spleen), and studying Overall Survival rates from first dosage until death due to any cause."

Answered by AI

Is enrollment currently open for this research study?

"Affirmative. Per the information on clinicaltrials.gov, recruitment for this medical trial is ongoing since its original posting on October 1st 2022 and latest update occurring 11 days later. The research team needs to recruit 70 participants from a sole location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

2022. "Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280509.

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