A Phase 2 interventional study of INCA33890 in CRC (Colorectal Cancer), sponsored by Incyte Corporation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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.
Has minimal residual disease (MRD), defined as ctDNA positive by the Signatera™ assay (whole exome sequencing [WES] or whole genome sequencing [WGS]) in a blood sample collected between:
Note: If the participant received any investigational therapy for MRD, ctDNA positivity must be confirmed in a blood sample collected at least 4 weeks after completion of that investigational therapy and within the applicable 12-month window described above.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
INCA33890 will be administered at the protocol-defined dose.
Drug: INCA33890
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
No study locations are listed for this record.
Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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