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TerminatedPhase 2NCT05027867
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKRT-232

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 16, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?Kartos Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Kartos Therapeutics, Inc.
Interventions being studied
Drug: KRT-232
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→Resistant or refractory→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer Specialists - 3840 BroadwayFort Myers, Florida
  • Florida Cancer Specialists - 560 Jackson St, Suite 220St. Petersburg, Florida
  • Florida Cancer SpecialistsWest Palm Beach, Florida
  • Northwest Georgia Oncology CentersMarietta, Georgia
  • Hematology Oncology ClinicBaton Rouge, Louisiana
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • Mark H Zangmeister Center - 3100 Plaza Properties BoulevardColumbus, Ohio
  • SCRI Tennessee Oncology ChattanoogaChattanooga, Tennessee
  • SCRI Tennessee Oncology NashvilleNashville, Tennessee
  • Flinders Medical CentreBedford Park, South Australia
  • Centre Hospitalier de Mulhouse - Hopital Emile MullerMulhouse, France/Haut-Rhin
  • Edog - Ico - PpdsAngers, Maine-et-Loire

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 16, 2023. Always confirm current availability with the study team.

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