Clinical trial · Interventional
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
| Small Cell Lung Cancer Recurrent | — | UNRESOLVED | — |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KRT-232 | Drug | Navtemadlin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
- interventionNames
- Drug: KRT-232
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
- interventionNames
- Drug: KRT-232
Primary outcomes (1)
- measure
- Objective response rate (ORR) of each arm
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available