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)

KRT-232-112

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.

2021-12-06

2022-08-26

2022-08-26

Terminated

Early phase I

3

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-08-16