Can a new drug wipe out hidden cancer DNA and stop colorectal cancer from returning?

NCT ID NCT07823322

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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