Clinical trial · Interventional
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
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)
NCT07823322CI-TRIAL-00126349NEXERA-204not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CRC (Colorectal Cancer) | Colorectal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCA33890 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCA33890
- description
- INCA33890 will be administered at the protocol-defined dose.
- interventionNames
- Drug: INCA33890
Primary outcomes (1)
- measure
- Circulating tumor DNA (ctDNA) clearance
- timeFrame
- 3 months
- description
- Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
Secondary outcomes (6)
- measure
- ctDNA clearance by visit
- timeFrame
- Up to approximately 19 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.