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Small Molecule Inhibitor
TL-895 + KRT-232 for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Telios Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed/Refractory to at least one prior therapy, one of which must have included a FLT-3 inhibitor
ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 41 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat FLT3 mutated Acute Myeloid Leukemia in adults who have failed other treatments.
Who is the study for?
Adults with a specific type of leukemia (FLT3 mutated Acute Myeloid Leukemia) who have tried other treatments without success can join this trial. They should not have had prior MDM2 antagonist therapies, be eligible for stem cell transplant, or have subtype 3 AML. Good overall function and no severe issues with blood, liver, or kidneys are required.Check my eligibility
What is being tested?
The study tests TL-895 combined with KRT-232 in patients. TL-895 is an oral drug that blocks certain proteins involved in cancer growth while KRT-232 targets a protein that helps cancer cells survive.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, fatigue, liver problems and lowered blood cell counts leading to increased infection risk. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after treatment, including a FLT-3 inhibitor.
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I am able to care for myself and perform daily activities.
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My AML does not have TP53 mutations.
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My cancer has a FLT3 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 41 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~41 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective, Phase 1b: To determine the MTD/MAD and recommended Phase 2 dose (RP2D) of TL-895 in combination with KRT-232
Primary Objective, Phase 2: To determine the rates of complete remission (CR) and complete remission with partial hematologic recovery (CRh)
Secondary outcome measures
Key Secondary Objective: To determine the duration of CR/CRh response (DOR)
Key Secondary Objective: To determine the overall response rate (ORR)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2 - Dose ExpansionExperimental Treatment2 Interventions
Dose expansion of the recommended phase 2 dose of TL-895 in combination with KRT-232 as determined in Phase 1b.
Group II: Phase 1b - Dose Level 5Experimental Treatment2 Interventions
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 450 mg BID continuously for the first 28-day cycle.
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 450 mg BID continuously for each 28-day cycle.
Group III: Phase 1b - Dose Level 4Experimental Treatment2 Interventions
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 300 mg BID continuously for the first 28-day cycle.
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 300 mg BID continuously for each 28-day cycle.
Group IV: Phase 1b - Dose Level 3Experimental Treatment2 Interventions
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 150 mg BID continuously for the first 28-day cycle
Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 150 mg BID continuously for each 28-day cycle.
Group V: Phase 1b - Dose Level 2Experimental Treatment2 Interventions
KRT-232 300mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
Group VI: Phase 1b - Dose Level 1Experimental Treatment2 Interventions
KRT-232 240mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
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
1,389 Total Patients Enrolled
Kartos Therapeutics, Inc.Industry Sponsor
15 Previous Clinical Trials
1,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is classified as AML subtype 3.My blood, liver, and kidney functions are all within normal ranges.I am eligible for a stem cell transplant.My condition did not improve after treatment, including a FLT-3 inhibitor.I am able to care for myself and perform daily activities.I have previously been treated with MDM2 antagonist therapies.My AML does not have TP53 mutations.My cancer has a FLT3 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b - Dose Level 5
- Group 2: Phase 2 - Dose Expansion
- Group 3: Phase 1b - Dose Level 1
- Group 4: Phase 1b - Dose Level 2
- Group 5: Phase 1b - Dose Level 3
- Group 6: Phase 1b - Dose Level 4
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.
What is the desired outcome of this experimental research?
"The primary objectives that Kartos Therapeutics, Inc. have set out to measure over the course of 13 months are complete remission (CR) and complete recovery with partial hematologic return (CRh). As secondary goals, they will also analyze overall response rate (ORR), duration of CR/CRh response (DOR), and the time to Cmax for TL-895 and KRT-232."
Answered by AI
What is the capacity of this research study?
"Affirmative. As per the information on clinicaltrials.gov, this medical study is actively recruiting and has been since March 31st 2021. The trial seeks to enlist 70 participants from 11 different centres of care."
Answered by AI
What prior studies have utilized TL-895 to explore its effects?
"TL-895 was first observed in 2017 at Huntsman Cancer Institute/University of Utah. As of now, 4 studies have been concluded and 13 experiments are underway, with a considerable number being conducted from Augusta, Georgia."
Answered by AI
Is this experiment currently open to new participants?
"As per the information provided on clinicaltrials.gov, this trial has been open for recruitment since March 31st 2021 and was last revised in October 11th 2022."
Answered by AI
How many healthcare organizations are currently administering this experiment?
"Georgia Cancer Center, Keck School of Medicine and Weill Cornell Medical College are three institutions running this clinical trial. Participants can also be enrolled at the additional 11 sites hosting the research project."
Answered by AI
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