KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
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.
Checked against the public recordLast updated Aug 16, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Kartos Therapeutics, Inc.
- Interventions being studied
- Drug: KRT-232
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Florida Cancer Specialists - 3840 BroadwayFort Myers, Florida
- Florida Cancer Specialists - 560 Jackson St, Suite 220St. Petersburg, Florida
- Florida Cancer SpecialistsWest Palm Beach, Florida
- Northwest Georgia Oncology CentersMarietta, Georgia
- Hematology Oncology ClinicBaton Rouge, Louisiana
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Mark H Zangmeister Center - 3100 Plaza Properties BoulevardColumbus, Ohio
- SCRI Tennessee Oncology ChattanoogaChattanooga, Tennessee
- SCRI Tennessee Oncology NashvilleNashville, Tennessee
- Flinders Medical CentreBedford Park, South Australia
- Centre Hospitalier de Mulhouse - Hopital Emile MullerMulhouse, France/Haut-Rhin
- Edog - Ico - PpdsAngers, Maine-et-Loire
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 16, 2023. Always confirm current availability with the study team.