KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Nov 15, 2025
  • participants needed
    38
  • sponsor
    Kartos Therapeutics, Inc.
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Updated on 15 July 2022
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Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.

Details
Condition Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
Treatment KRT-232
Clinical Study IdentifierNCT05027867
SponsorKartos Therapeutics, Inc.
Last Modified on15 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
Disease must be measurable per RECIST Version 1.1
Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse
Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available
ECOG ≤ 2

Exclusion Criteria

Symptomatic or uncontrolled central nervous system (CNS) metastases
Prior treatment with MDM2 inhibitors
Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
History of major organ transplant
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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