Lung Cancer Clinical Trial
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
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 Criteria
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
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There are 30 Locations for this study
Fort Myers Florida, 33901, United States More Info
Principal Investigator
Saint Petersburg Florida, 33705, United States More Info
Principal Investigator
West Palm Beach Florida, 33401, United States More Info
Principal Investigator
Marietta Georgia, 30060, United States More Info
Principal Investigator
Baton Rouge Louisiana, 70809, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Columbus Ohio, 43213, United States More Info
Principal Investigator
Chattanooga Tennessee, 37404, United States More Info
Principal Investigator
Nashville Tennessee, 37205, United States More Info
Principal Investigator
Mulhouse France/Haut-Rhin, 68000, France More Info
Principal Investigator
Angers Maine-et-Loire, 49933, France More Info
Principal Investigator
Bron Rhône, 69677, France More Info
Principal Investigator
Lyon Rhône, 69495, France More Info
Principal Investigator
Pierre-Bénite Rhône, 69310, France More Info
Principal Investigator
Bordeaux , 33000, France More Info
Principal Investigator
Immenhausen Hessen, 34376, Germany More Info
Principal Investigator
Berlin , 13125, Germany More Info
Principal Investigator
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of More Info
Principal Investigator
Seongnam-si Gyeonggido, 13520, Korea, Republic of More Info
Principal Investigator
Pamplona Navarra, 31008, Spain More Info
Principal Investigator
Alicante , 28007, Spain More Info
Principal Investigator
Alicante , 3010, Spain More Info
Principal Investigator
Barcelona , 0825, Spain More Info
Principal Investigator
Madrid , 28027, Spain More Info
Principal Investigator
Madrid , 28046, Spain More Info
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Principal Investigator
Málaga , 29011, Spain More Info
Principal Investigator
Sevilla , 41071, Spain More Info
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Principal Investigator
Valencia , 46026, Spain More Info
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Principal Investigator
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