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

NCT05027867 | Terminated Phase 2 FDA Drug

• 1 other identifier: KRT-232-112
• Study Type: interventional
• Target: 3
• Locations: 7 countries
• Sites: 33

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.

Conditions

Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent

Keywords

navtemadlin

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) of each arm

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

  24 weeks

Secondary Outcomes (4)

• Duration of response (DOR) of each arm

  1 year

• Progression-free survival (PFS) of each arm

  1 year

• Overall survival (OS) of each arm

  1 year

• Disease control rate (DCR) of each arm

  24 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: KRT-232

Arm 2

EXPERIMENTAL

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

Drug: KRT-232

Interventions

KRT-232 DRUG

Administered by mouth

Also known as: navtemadlin

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kartos Therapeutics, Inc.: lead

Study Sites (33)

Florida Cancer Specialists - 3840 Broadway

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists - 560 Jackson St, Suite 220

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Northwest Georgia Oncology Centers

Marietta, Georgia, 30060, United States

Location

Hematology Oncology Clinic

Baton Rouge, Louisiana, 70809, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Mark H Zangmeister Center - 3100 Plaza Properties Boulevard

Columbus, Ohio, 43213, United States

Location

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

SCRI Tennessee Oncology Nashville

Nashville, Tennessee, 37205, United States

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Centre Hospitalier de Mulhouse - Hopital Emile Muller

Mulhouse, France/Haut-Rhin, 68000, France

Location

Edog - Ico - Ppds

Angers, Maine-et-Loire, 49933, France

Location

Hôpital Louis Pradel

Bron, Rhône, 69677, France

Location

Hospices Civils de Lyon

Lyon, Rhône, 69495, France

Location

Hôpital de La Croix Rousse

Pierre-Bénite, Rhône, 69310, France

Location

EDOG - Institut Bergonie - PPDS

Bordeaux, 33000, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hopital Nord AP-HM

Marseille, 13915, France

Location

Klinik für Kardiologie, Angiologie und Pneumologie

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

Bacs Kiskun Megyei Korhaz

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggido, 13520, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario 12 de Octubre

Alicante, 28007, Spain

Location

Hospital General Universitario de Alicante

Alicante, 3010, Spain

Location

Hospital Universitario Vall d'Hebrón - PPDS

Barcelona, 0825, Spain

Location

Clinica Universidad Navarra - Madrid

Madrid, 28027, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga - Hospital Civil

Málaga, 29011, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41071, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

navtemadlin; 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: December 6, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

DE (3); KR (2); ES (9); AU (1); US (9); HU (1); FR (8)