A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)

A Phase 2 Study of INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)

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 Overview

• Status: Not yet recruiting
• Conditions: CRC (Colorectal Cancer)
• Intervention / Treatment: Drug: INCA33890

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Received curative-intent (R0) resection of histologically confirmed Stage II or III colorectal adenocarcinoma.
• Completed all neoadjuvant and/or adjuvant chemotherapy, including at least 3 months of fluoropyrimidine-based 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:

  • 2 weeks and 12 months after completion of adjuvant chemotherapy or
  • 4 weeks and 12 months after curative resection following total neoadjuvant therapy.

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.

• Has no clinical or radiographic evidence of disease confirmed by chest, abdominal, and pelvic PET-CT scan and by brain imaging (MRI or CT scan with contrast) within 4 weeks prior to C1D1 study drug administration.
• ECOG performance status of 0 or 1.
• Adequate organ function determined by laboratory results.

Exclusion Criteria:

• History of metastatic (Stage IV) colorectal adenocarcinoma, including oligometastatic disease or metastatic recurrence, even if all metastatic sites and the primary tumor were completely resected and the patient is currently without evidence of disease.
• MSI-H/dMMR per historical data in the medical record.
• History of other malignancy within 2 years.
• Treatment with an anti-PD-(L)1 or anti-CTLA-4 for any indication within the last 3 years.
• Active autoimmune disease that has required systemic treatment in the past 2 years.
• Significant concurrent and/or uncontrolled medical condition.
• History of organ transplant, including allogeneic stem cell transplantation.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCA33890; INCA33890 will be administered at the protocol-defined dose.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor DNA (ctDNA) clearance	Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA clearance by visit	Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.	Up to approximately 19 months
Absolute change from baseline in ctDNA levels at each visit		Up to approximately 19 months
Percent change from baseline in ctDNA levels at each visit		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.	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.	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.	Up to approximately 19 months

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colon Cancer; Minimal residual disease (MRD); Circulating tumor DNA (ctDNA); Signatera; INCA33890
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Neoplasm, Residual; Colonic Neoplasms
• Other Study ID Numbers: INCA033890-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No