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

Stopped early · Phase 2

Conditions studied: Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent

In brief

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.

Key facts

Study ID

NCT05027867

Run by

Kartos Therapeutics, Inc.

People needed

3

Starts

2021-12-06

Expected to finish

2022-08-26

Last updated by the study team

2023-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Florida Cancer Specialists - 3840 Broadway — Fort Myers, Florida, United States
• Florida Cancer Specialists - 560 Jackson St, Suite 220 — St. Petersburg, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Northwest Georgia Oncology Centers — Marietta, Georgia, United States
• Hematology Oncology Clinic — Baton Rouge, Louisiana, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Mark H Zangmeister Center - 3100 Plaza Properties Boulevard — Columbus, Ohio, United States
• SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• SCRI Tennessee Oncology Nashville — Nashville, Tennessee, United States
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Centre Hospitalier de Mulhouse - Hopital Emile Muller — Mulhouse, France/Haut-Rhin, France
• Edog - Ico - Ppds — Angers, Maine-et-Loire, France
• Hôpital Louis Pradel — Bron, Rhône, France
• Hospices Civils de Lyon — Lyon, Rhône, France
• Hôpital de La Croix Rousse — Pierre-Bénite, Rhône, France
• EDOG - Institut Bergonie - PPDS — Bordeaux, France
• CHU de Grenoble — Grenoble, France
• Hopital Nord AP-HM — Marseille, France
• Klinik für Kardiologie, Angiologie und Pneumologie — Esslingen am Neckar, Baden-Wurttemberg, Germany
• Lungenfachklinik Immenhausen — Immenhausen, Hesse, Germany
• Evangelische Lungenklinik Berlin — Berlin, Germany
• Bacs Kiskun Megyei Korhaz — Kecskemét, Bács-Kiskun county, Hungary
• CHA Bundang Medical Center, CHA University — Seongnam-si, Gyeonggido, South Korea
• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea
• Clinica Universidad Navarra — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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