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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Administered by mouth
Objective response rate (ORR) of each arm
The proportion of subjects achieving partial response or better per RECIST 1.1
Time frame: 24 weeks
Duration of response (DOR) of each arm
Time from initiation of response to disease progression or death
Time frame: 1 year
Progression-free survival (PFS) of each arm
Time from first dose to disease progression or death
Time frame: 1 year
Overall survival (OS) of each arm
Time from first dose to death
Time frame: 1 year
Disease control rate (DCR) of each arm
The proportion of subjects achieving stable disease or better per RECIST 1.1
Time frame: 24 weeks
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