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

Study Overview
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Brief Summary
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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.

Official Title
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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)

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

Intervention / Treatment
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* Drug: KRT-232


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) | Drug: KRT-232<br>* Administered by mouth<br>* Other names: navtemadlin;|
| Experimental: Arm 2<br>KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) | Drug: KRT-232<br>* Administered by mouth<br>* Other names: navtemadlin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) of each arm | The proportion of subjects achieving partial response or better per RECIST 1.1 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (DOR) of each arm | Time from initiation of response to disease progression or death | 1 year | 
| Progression-free survival (PFS) of each arm | Time from first dose to disease progression or death | 1 year | 
| Overall survival (OS) of each arm | Time from first dose to death | 1 year | 
| Disease control rate (DCR) of each arm | The proportion of subjects achieving stable disease or better per RECIST 1.1 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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navtemadlin