Your session is about to expire
← Back to Search
Other
KRT-232 + TL-895 for Myelofibrosis
Phase 1 & 2
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG ≤ 2
Cohort 1 and Cohort 2: R/R following JAK inhibitor treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
Study Summary
This trial is testing a new drug, KRT-232, to see if it can help treat myelofibrosis, a bone marrow disorder.
Who is the study for?
This trial is for adults with a confirmed diagnosis of primary or secondary myelofibrosis who have either not responded to JAK inhibitor treatment or cannot tolerate it. Participants should be relatively active (ECOG ≤ 2) and haven't had certain treatments like BCR-ABL inhibitors, splenectomy, or specific cancer therapies recently.Check my eligibility
What is being tested?
The study is testing KRT-232 in combination with TL-895 for those whose myelofibrosis has relapsed after treatment, as well as KRT-232 alone for patients intolerant to JAK inhibitors. It aims to evaluate the effectiveness and safety of these combinations.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal symptoms, changes in blood counts leading to increased risk of infections or bleeding, liver enzyme alterations, fatigue, and possible heart rhythm abnormalities due to QTc prolongation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have relapsed or didn't respond after JAK inhibitor treatment.
Select...
I have been diagnosed with a form of myelofibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b - The MTD/MAD and RP2D of TL-895 in combination with KRT-232 in patients with R/R MF (Cohort 1 and Cohort 2)
Phase 2 - Spleen response rate for each cohort
Secondary outcome measures
Total Symptom Score (TSS)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 3 (JAKi Intolerant MF)Experimental Treatment1 Intervention
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.
Group II: Cohort 2 (R/R MF), Dose Level 2Experimental Treatment2 Interventions
TL-895 at 150 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
Group III: Cohort 2 (R/R MF), Dose Level 1Experimental Treatment2 Interventions
TL-895 at 100 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
Group IV: Cohort 1 (R/R MF), Dose Level 2Experimental Treatment2 Interventions
TL-895 at 300 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
Group V: Cohort 1 (R/R MF), Dose Level 1Experimental Treatment2 Interventions
TL-895 at 200 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.
KRT-232 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.
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?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,334 Total Patients Enrolled
Telios Pharma, Inc.Industry Sponsor
9 Previous Clinical Trials
1,291 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate JAK inhibitor treatment.I have previously been treated with MDM2 inhibitors or p53 therapies.I have had my spleen removed.I have not had radiation to my spleen in the last 3 months.I have been treated with specific cancer drugs before.I have not had a significant blood clot in the past 3 months.I can take care of myself and am up and about more than 50% of my waking hours.I have relapsed or didn't respond after JAK inhibitor treatment.I have been diagnosed with a form of myelofibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (R/R MF), Dose Level 1
- Group 2: Cohort 1 (R/R MF), Dose Level 2
- Group 3: Cohort 2 (R/R MF), Dose Level 2
- Group 4: Cohort 1 (R/R MF), Dose Level 1
- Group 5: Cohort 3 (JAKi Intolerant MF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a plethora of medical facilities running this research trial within the state?
"For the time being, this medical trial is recruiting patients at 6 different sites throughout Birmingham, Lake City and Urbana as well as other nearby towns. For convenience sake, it would be wise to pick a clinic situated in close proximity so you can reduce your travelling costs if accepted into the study."
Answered by AI
Is this research initiative accepting new participants?
"Indeed, according to clinicaltrials.gov, this investigation is recruiting participants. It was initially posted on November 17th 2020 and recently adjusted on May 5th 2022; it requires 116 volunteers across six medical sites."
Answered by AI
Are there any existing accounts of TL-895's use in prior clinical research?
"At present, 13 scientific studies are underway to research TL-895 with one in its final phase. Katowice and New york make up the bulk of these trials; however, a total of 582 sites across the globe have taken part in investigations concerning TL-895."
Answered by AI
How many participants are included in the research project?
"This research calls for 116 qualified participants. The University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology in the city of Birmingham (Alabama) as well as Lake City Cancer Center in Florida are two locations hosting this trial."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger