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

Sponsor
Kartos Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05027867
Collaborator
(none)
38
Enrollment
30
Locations
2
Arms
46.9
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 6, 2021
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) of each arm [24 weeks]

      The proportion of subjects achieving partial response or better per RECIST 1.1

    Secondary Outcome Measures

    1. Duration of response (DOR) of each arm [1 year]

      Time from initiation of response to disease progression or death

    2. Progression-free survival (PFS) of each arm [1 year]

      Time from first dose to disease progression or death

    3. Overall survival (OS) of each arm [1 year]

      Time from first dose to death

    4. Disease control rate (DCR) of each arm [24 weeks]

      The proportion of subjects achieving stable disease or better per RECIST 1.1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Cancer Specialists - 3840 Broadway Fort Myers Florida United States 33901
    2 Florida Cancer Specialists - 560 Jackson St, Suite 220 Saint Petersburg Florida United States 33705
    3 Florida Cancer Specialists West Palm Beach Florida United States 33401
    4 Northwest Georgia Oncology Centers Marietta Georgia United States 30060
    5 Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
    6 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    7 Mark H Zangmeister Center - 3100 Plaza Properties Boulevard Columbus Ohio United States 43213
    8 SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    9 SCRI Tennessee Oncology Nashville Nashville Tennessee United States 37205
    10 Centre Hospitalier de Mulhouse - Hopital Emile Muller Mulhouse France/Haut-Rhin France 68000
    11 Edog - Ico - Ppds Angers Maine-et-Loire France 49933
    12 Hôpital Louis Pradel Bron Rhône France 69677
    13 Hospices Civils de Lyon Lyon Rhône France 69495
    14 Hôpital de La Croix Rousse Pierre-Bénite Rhône France 69310
    15 EDOG - Institut Bergonie - PPDS Bordeaux France 33000
    16 CHU de Grenoble Grenoble France 38043
    17 Hopital Nord AP-HM Marseille France 13915
    18 Lungenfachklinik Immenhausen Immenhausen Hessen Germany 34376
    19 Evangelische Lungenklinik Berlin Berlin Germany 13125
    20 Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do Korea, Republic of 28644
    21 CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggido Korea, Republic of 13520
    22 Clinica Universidad Navarra Pamplona Navarra Spain 31008
    23 Hospital Universitario 12 de Octubre Alicante Spain 28007
    24 Hospital General Universitario de Alicante Alicante Spain 3010
    25 Hospital Universitario Vall d'Hebrón - PPDS Barcelona Spain 0825
    26 Clinica Universidad Navarra - Madrid Madrid Spain 28027
    27 Hospital Universitario La Paz Madrid Spain 28046
    28 Hospital Regional Universitario de Malaga - Hospital Civil Málaga Spain 29011
    29 Hospital Universitario Virgen Macarena Sevilla Spain 41071
    30 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026

    Sponsors and Collaborators

    • Kartos Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kartos Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05027867
    Other Study ID Numbers:
    • KRT-232-112
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kartos Therapeutics, Inc.
    navtemadlin
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Jun 21, 2022