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

August 14, 2023 updated by: Kartos Therapeutics, Inc.

An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
  • France
      • Bordeaux, France, 33000
        • EDOG - Institut Bergonie - PPDS
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Marseille, France, 13915
        • Hopital Nord AP-HM
    • France/Haut-Rhin
      • Mulhouse, France/Haut-Rhin, France, 68000
        • Centre Hospitalier de Mulhouse - Hopital Emile Muller
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Edog - Ico - Ppds
    • Rhône
      • Bron, Rhône, France, 69677
        • Hôpital Louis Pradel
      • Lyon, Rhône, France, 69495
        • Hospices Civils de Lyon
      • Pierre-Bénite, Rhône, France, 69310
        • Hôpital de La Croix Rousse
  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
    • Baden-Württemberg
      • Esslingen am Neckar, Baden-Württemberg, Germany, 73730
        • Klinik für Kardiologie, Angiologie und Pneumologie
    • Hessen
      • Immenhausen, Hessen, Germany, 34376
        • Lungenfachklinik Immenhausen
  • Hungary
    • Bács-Kiskun
      • Kecskemét, Bács-Kiskun, Hungary, 6000
        • Bacs Kiskun Megyei Korhaz
  • Korea, Republic of
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • Chungbuk National University Hospital
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13520
        • CHA Bundang Medical Center, CHA University
  • Spain
      • Alicante, Spain, 3010
        • Hospital General Universitario de Alicante
      • Alicante, Spain, 28007
        • Hospital Universitario 12 de Octubre
      • Barcelona, Spain, 0825
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28027
        • Clinica Universidad Navarra - Madrid
      • Málaga, Spain, 29011
        • Hospital Regional Universitario de Malaga - Hospital Civil
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad Navarra
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - 3840 Broadway
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists - 560 Jackson St, Suite 220
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43213
        • Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Scri Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37205
        • SCRI Tennessee Oncology Nashville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Drug: KRT-232
Administered by mouth
Other Names:
  • navtemadlin
Experimental: Arm 2
KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Drug: KRT-232
Administered by mouth
Other Names:
  • navtemadlin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) of each arm
Time Frame: 24 weeks
The proportion of subjects achieving partial response or better per RECIST 1.1
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) of each arm
Time Frame: 1 year
Time from initiation of response to disease progression or death
1 year
Progression-free survival (PFS) of each arm
Time Frame: 1 year
Time from first dose to disease progression or death
1 year
Overall survival (OS) of each arm
Time Frame: 1 year
Time from first dose to death
1 year
Disease control rate (DCR) of each arm
Time Frame: 24 weeks
The proportion of subjects achieving stable disease or better per RECIST 1.1
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartos Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Actual)

August 26, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRT-232-112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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