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

Primary Purpose

Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KRT-232
Sponsored by
Kartos Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring navtemadlin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Cancer Specialists - 3840 Broadway
  • Florida Cancer Specialists - 560 Jackson St, Suite 220
  • Florida Cancer Specialists
  • Northwest Georgia Oncology Centers
  • Hematology Oncology Clinic
  • University Hospitals Cleveland Medical Center
  • Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
  • SCRI Tennessee Oncology Chattanooga
  • SCRI Tennessee Oncology Nashville
  • Flinders Medical Centre
  • Centre Hospitalier de Mulhouse - Hopital Emile Muller
  • Edog - Ico - Ppds
  • Hôpital Louis Pradel
  • Hospices Civils de Lyon
  • Hôpital de La Croix Rousse
  • EDOG - Institut Bergonie - PPDS
  • CHU de Grenoble
  • Hopital Nord AP-HM
  • Klinik für Kardiologie, Angiologie und Pneumologie
  • Lungenfachklinik Immenhausen
  • Evangelische Lungenklinik Berlin
  • Bacs Kiskun Megyei Korhaz
  • Chungbuk National University Hospital
  • CHA Bundang Medical Center, CHA University
  • Clinica Universidad Navarra
  • Hospital Universitario 12 de Octubre
  • Hospital General Universitario de Alicante
  • Hospital Universitario Vall d'Hebrón - PPDS
  • Clinica Universidad Navarra - Madrid
  • Hospital Universitario La Paz
  • Hospital Regional Universitario de Malaga - Hospital Civil
  • Hospital Universitario Virgen Macarena
  • Hospital Universitari i Politecnic La Fe de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Outcomes

Primary Outcome Measures

Objective response rate (ORR) of each arm
The proportion of subjects achieving partial response or better per RECIST 1.1

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2021
Last Updated
August 14, 2023
Sponsor
Kartos Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05027867
Brief Title
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kartos Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
Keywords
navtemadlin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
KRT-232
Other Intervention Name(s)
navtemadlin
Intervention Description
Administered by mouth
Primary Outcome Measure Information:
Title
Objective response rate (ORR) of each arm
Description
The proportion of subjects achieving partial response or better per RECIST 1.1
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Duration of response (DOR) of each arm
Description
Time from initiation of response to disease progression or death
Time Frame
1 year
Title
Progression-free survival (PFS) of each arm
Description
Time from first dose to disease progression or death
Time Frame
1 year
Title
Overall survival (OS) of each arm
Description
Time from first dose to death
Time Frame
1 year
Title
Disease control rate (DCR) of each arm
Description
The proportion of subjects achieving stable disease or better per RECIST 1.1
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Florida Cancer Specialists - 3840 Broadway
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists - 560 Jackson St, Suite 220
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northwest Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
SCRI Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Centre Hospitalier de Mulhouse - Hopital Emile Muller
City
Mulhouse
State/Province
France/Haut-Rhin
ZIP/Postal Code
68000
Country
France
Facility Name
Edog - Ico - Ppds
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Louis Pradel
City
Bron
State/Province
Rhône
ZIP/Postal Code
69677
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Pierre-Bénite
State/Province
Rhône
ZIP/Postal Code
69310
Country
France
Facility Name
EDOG - Institut Bergonie - PPDS
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Nord AP-HM
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Klinik für Kardiologie, Angiologie und Pneumologie
City
Esslingen am Neckar
State/Province
Baden-Württemberg
ZIP/Postal Code
73730
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
State/Province
Hessen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Bacs Kiskun Megyei Korhaz
City
Kecskemét
State/Province
Bács-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Alicante
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón - PPDS
City
Barcelona
ZIP/Postal Code
0825
Country
Spain
Facility Name
Clinica Universidad Navarra - Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga - Hospital Civil
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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