Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
Conditions
Keywords
navtemadlin
Brief 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.
Interventions
DRUGKRT-232
Administered by mouth
Sponsors
Kartos Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) of each arm | 24 weeks | The proportion of subjects achieving partial response or better per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) of each arm | 1 year | Time from initiation of response to disease progression or death |
| Progression-free survival (PFS) of each arm | 1 year | Time from first dose to disease progression or death |
| Overall survival (OS) of each arm | 1 year | Time from first dose to death |
| Disease control rate (DCR) of each arm | 24 weeks | The proportion of subjects achieving stable disease or better per RECIST 1.1 |
Countries
Australia, France, Germany, Hungary, South Korea, Spain, United States
Outcome results
None listed