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)

Who is this study for? Patients with relapsed or refractory small cell lung cancer
What treatments are being studied? KRT-232
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Florida
Florida Cancer Specialists - 3840 Broadway
Recruiting
Fort Myers
Florida Cancer Specialists - 560 Jackson St, Suite 220
Recruiting
Saint Petersburg
Florida Cancer Specialists
Recruiting
West Palm Beach
Georgia
Northwest Georgia Oncology Centers
Recruiting
Marietta
Louisiana
Hematology Oncology Clinic
Recruiting
Baton Rouge
Ohio
University Hospitals Cleveland Medical Center
Recruiting
Cleveland
Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
Recruiting
Columbus
Tennessee
SCRI Tennessee Oncology Chattanooga
Recruiting
Chattanooga
SCRI Tennessee Oncology Nashville
Recruiting
Nashville
Other Locations
France
Edog - Ico - Ppds
Recruiting
Angers
EDOG - Institut Bergonie - PPDS
Recruiting
Bordeaux
Hôpital Louis Pradel
Recruiting
Bron
CHU de Grenoble
Recruiting
Grenoble
Hospices Civils de Lyon
Recruiting
Lyon
Hopital Nord AP-HM
Recruiting
Marseille
Centre Hospitalier de Mulhouse - Hopital Emile Muller
Recruiting
Mulhouse
Hôpital de La Croix Rousse
Recruiting
Pierre-bénite
Germany
Evangelische Lungenklinik Berlin
Recruiting
Berlin
Lungenfachklinik Immenhausen
Recruiting
Immenhausen
Republic of Korea
Chungbuk National University Hospital
Recruiting
Cheongju-si
CHA Bundang Medical Center, CHA University
Recruiting
Seongnam-si
Spain
Hospital General Universitario de Alicante
Recruiting
Alicante
Hospital Universitario 12 de Octubre
Recruiting
Alicante
Hospital Universitario Vall d'Hebrón - PPDS
Recruiting
Barcelona
Clinica Universidad Navarra - Madrid
Recruiting
Madrid
Hospital Universitario La Paz
Recruiting
Madrid
Hospital Regional Universitario de Malaga - Hospital Civil
Recruiting
Málaga
Clinica Universidad Navarra
Recruiting
Pamplona
Hospital Universitario Virgen Macarena
Recruiting
Sevilla
Hospital Universitari i Politecnic La Fe de Valencia
Recruiting
Valencia
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Time Frame
Start Date: December 6, 2021
Estimated Completion Date: November 2025
Participants
Target number of participants: 38
Treatments
Experimental: Arm 1
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Experimental: Arm 2
KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Authors
Davey Daniel, Afshin Dowlati, Fadi Kayali, Luis Paz-Ares Rodriguez, Eric Harris, Steven McCune, Michael Castine, Vijay Patel, Joo Hang Kim, Didier Debieuvre, Achim Rittmeyer, Sébastien Couraud, Denis Moro-Sibilot, Christian Grohé, Laurent Greillier, Sophie Cousin, Sandrine Hiret, Bartomeu Massuti Sureda, Melissa Johnson, Jorge Rios Perez, Sebastian Couraud, Ki Hyeong Lee, Ignacio Gil Bazo, Oscar Jose Juan Vidal, David Vicente Baz, Vanesa Gutierrez Calderon, Alejandro Navarro Mendivil, Javier De Castro Carpeño
Sponsors
Leads: Kartos Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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