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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

Must not have

Prior treatment with MDM2 inhibitors or p53-directed therapies

Prior splenectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have relapsed or didn't respond after JAK inhibitor treatment.

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I have been diagnosed with a form of myelofibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with MDM2 inhibitors or p53 therapies.

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I have had my spleen removed.

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I have been treated with specific cancer drugs before.

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I have not had a significant blood clot in the past 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Total Symptom Score (TSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met