The purpose of this study is to evaluate INCA33890 in the treatment of circulating tumor DNA-positive stage II/III microsatellite stable colorectal cancer after curative resection and chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
INCA33890 will be administered at protocol defined dose.
Circulating tumor DNA (ctDNA) clearance
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
Time frame: 3 months
ctDNA clearance by visit
Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.
Time frame: Up to approximately 19 months
Absolute change from baseline in ctDNA levels at each visit
Time frame: Up to approximately 19 months
Percent change from baseline in ctDNA levels at each visit
Time frame: Up to approximately 19 months
Disease-free survival (DFS)
Defined as the time from the date of first dose of study drug to the date of recurrence, second primary CRC malignancy, or death from any cause, whichever occurs first.
Time frame: Up to approximately 19 months
Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug and up to 90 days after last dose of INCA33890 or the start of new anticancer therapy, whichever comes first.
Time frame: Up to approximately 19 months
TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment
TEAEs leading to dose interruption, dose delay or study drug discontinuation.
Time frame: Up to approximately 19 months
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