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

NCT07823322 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: INCA033890-204
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CRC (Colorectal Cancer)

Keywords

Colorectal Cancer; Colon Cancer; INCA33890; Circulating tumor DNA (ctDNA); Signatera; Minimal residual disease (MRD)

Outcome Measures

Primary Outcomes (1)

• Circulating tumor DNA (ctDNA) clearance

  Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.

  3 months

Secondary Outcomes (6)

• ctDNA clearance by visit

  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)

  Up to approximately 19 months

• Treatment Emergent Adverse Events (TEAEs)

  Up to approximately 19 months

Study Arms (1)

INCA33890

EXPERIMENTAL

INCA33890 will be administered at the protocol-defined dose.

Drug: INCA33890

Interventions

INCA33890 DRUG

INCA33890 will be administered at protocol defined dose.

INCA33890

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• weeks and 12 months after completion of adjuvant chemotherapy or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Related Links

• 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

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.