Can a new drug wipe out hidden cancer DNA and stop colorectal cancer from returning?
NCT ID NCT07823322
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing an experimental drug called INCA33890 in people with stage II or III colorectal cancer who have finished surgery and chemotherapy but still have tiny amounts of tumor DNA in their blood. This leftover DNA, called circulating tumor DNA or ctDNA, can signal that cancer cells remain and may return. The trial gives INCA33890 to 40 participants to see whether it can clear ctDNA from the blood within three months. The goal is to learn if treating this hidden cancer signal can help prevent the cancer from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INCA33890, an experimental cancer drug
- What this could lead to
- If INCA33890 clears ctDNA, it could offer a way to treat lingering cancer cells after surgery and chemotherapy, possibly lowering the chance of the cancer returning.
- What could go wrong
- This is a small phase 2 trial with 40 participants, so results may not hold in larger groups. Clearing ctDNA does not guarantee the cancer will not come back, and the drug may cause side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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Contact
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