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Chronic Myeloid LeukemiaPhase 1/2NCT04835584

KRT-232 and TKI Study in Chronic Myeloid Leukemia

A Phase 1/2 study testing KRT-232, Dasatinib and Nilotinib in people with Chronic Myeloid Leukemia, run by Kartos Therapeutics, Inc. at 26 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
KRT-232, Dasatinib and Nilotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
26 sitesin 8 countries
Study dates
7 May 2021to 30 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP
  • Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP
  • Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
  • Adults ≥ 18 years of age.
  • ECOG performance status of 0 to 2
  • Adequate hematologic, hepatic, and renal functions

Who cannot join

  • Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP
  • Documented Ph+, BCR-ABL+ CML-BC
  • Known T315I mutation.
  • Prior treatment with MDM2 antagonist therapies.
  • Intolerance to current TKI therapy.

Trial locations and contacts

26 sites in 8 countries.

John Mei contact

650-542-0136

jmei@kartosthera.com

26 sites in 8 countries

United States5 sites, 5 recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Texas Oncology- Sammons CC at Baylor

    Dallas, Texas, 75246

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

Other trials in United States

France4 sites, 4 recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • APHM Hopital de la Timone

    Marseille, 13005

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Recruiting

  • Centre Hospitalier Lyon Sud

    Saint-Genis-Laval, 69310

    Recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • Azienda Ospedaliero - Universitaria Mater Domini

    Catanzaro, 88100

    Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola FC, 47014

    Recruiting

  • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

    Milan, MI, 20122

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

Other trials in Italy

South Korea4 sites, 4 recruiting

  • Kyungpook National University Hospital

    Daegu

    Recruiting

  • Samsung Medical Center

    Seoul, 135-710

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital

    Seoul

    Recruiting

Other trials in South Korea

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Clínica Universidad de Navarra

    Madrid, Navarre, 28027

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Recruiting

Other trials in Spain

Russia3 sites, 3 recruiting

  • National Medical Research Center of Hematology

    Moscow, 125167

    Recruiting

  • Almazov National Medical Research Center

    Saint Petersburg, 197341

    Recruiting

  • Samara State Medical University

    Samara, 443001

    Recruiting

Other trials in Russia

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2C1

    Recruiting

Other trials in Canada

Poland1 site, 1 recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    Recruiting

Other trials in Poland

About this study

Official title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Being tested
KRT-232, Dasatinib, Nilotinib
Keywords
navtemadlin
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KRT-232Drug

    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.

  • DasatinibDrug

    Also called Dasatinib Zentiva

    Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

  • NilotinibDrug

    Also called Tasigna

    Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

Study groups in NCT04835584
Study groupRoleWhat they receive
Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CPExperimentalKRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. TKI (dasatinib or nilotinib) will be administered orally, per locally prescribed dose and schedule.
Receives: Drug: KRT-232; Drug: Dasatinib; Drug: Nilotinib
Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)ExperimentalKRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasastinib will be administered orally, per locally prescribed dose and schedule.
Receives: Drug: KRT-232; Drug: Dasatinib
Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)ExperimentalKRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Nilotinib will be administered orally, per locally prescribed dose and schedule.
Receives: Drug: KRT-232; Drug: Nilotinib
Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)ExperimentalKRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasatinib or Nilotinib will be administered orally, per locally prescribed dose and schedule.
Receives: Drug: KRT-232; Drug: Dasatinib; Drug: Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232

    DLTs will be used to establish the MTD/MAD of KRT-232 in combination with dasatinib or nilotinib

    Measured: 28 Days

  2. Part 2, Arm A and B: Major molecular response (MMR) rate

    The proportion of subjects who achieved complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) according to modified ELN criteria

    Measured: 6 months

  3. Part 2, Arm C: Major hematological response (MaHR) rate

    The proportion of subjects who achieved MaHR according to modified ELN criteria

    Measured: 6 months

Secondary outcomes (6)

  1. CCyR rate

    The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arms A and B

    Measured: 12 months

  2. MCyR rate

    The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arm C

    Measured: 47 months

  3. Duration of response

    DOR (Kaplan-Meier estimate) defined as the time from first observation of response to progression/relapse or death, whichever comes first

    Measured: 47 months

  4. Rate of complete hematologic response (CHR)

    The proportion of subjects who achieve a CHR according to modified ELN criteria in Arms A and B

    Measured: 47 months

  5. Progression-free survival (PFS) in each Arm

    PFS is defined as the time from the first treatment dose date to progression/relapse or death, whichever comes first

    Measured: 47 months

  6. Overall survival (OS) in each Arm

    OS is defined as the time from the first treatment dose date to death from any cause

    Measured: 47 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start7 May 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835584
Sponsor's protocol ID
KRT-232-117
Status last verified
Mar 2022
First submitted
5 Apr 2021
Last updated
21 Mar 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KRT-232, Dasatinib and Nilotinib in people with Chronic Myeloid Leukemia, run by Kartos Therapeutics, Inc. at 26 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, France, Italy, South Korea, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact John Mei (650-542-0136, jmei@kartosthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232 (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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