Can a targeted drug conjugate outsmart advanced colorectal cancer?

NCT ID NCT07805369

What the study statuses mean

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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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase 1 trial tests an investigational drug called DEM301 in adults with advanced colorectal cancer that has progressed after standard treatments. DEM301 is an antibody-drug conjugate, a type of therapy designed to deliver a toxic agent directly to cancer cells. The study aims to find safe doses, understand how the drug behaves in the body, and look for early signs that it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DEM301, an investigational antibody-drug conjugate
What this could lead to
If DEM301 proves safe and shows anti-tumor activity, it could become a new treatment option for people with advanced colorectal cancer who have exhausted standard therapies.
What could go wrong
This is an early, first-in-human study with a small number of participants. The drug may not shrink tumors or may cause side effects that limit its use. Success in this phase does not guarantee later approval.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 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: 1. Age ≥18 years. 2. Participants must have documented advanced (metastatic or unresectable) colorectal cancer that has progressed on or after prior standard-of-care treatment and must have received, or been unable to receive, applicable standard therapies as defined in the protocol. 3. Life expectancy ≥12 weeks. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Have at least 1 measurable lesion at baseline suitable for repeat imaging evaluation by RECIST v1.1. 6. Adequate bone marrow, liver, kidney, and coagulation function per protocol requirements. 7. Agree to provide adequate tumor tissue for protocol-required biomarker assessment. Participants in designated cohorts must be willing to provide fresh tumor biopsies, unless medically contraindicated. 8. Female participants must not be pregnant or breastfeeding. Male and female participants must comply with protocol-defined reproductive and contraception requirements. 9. Have suitable venous access for study treatment and required blood sampling. 10. Be willing and able to comply with study assessments, schedule, and restrictions. 11. Written informed consent must be obtained before any study-related procedures are performed. Exclusion Criteria: 1. Prior treatment with certain antibody-drug conjugates, as defined in the protocol. Protocol-defined exceptions may apply. 2. Recent anticancer therapy, investigational treatment, major surgery, or radiation therapy within the protocol-defined washout periods. 3. Ongoing clinically significant toxicity from prior therapy that has not recovered to the protocol-required level. 4. Active central nervous system (CNS) metastases or suspected or confirmed leptomeningeal disease. Participants with treated and stable brain metastases may be eligible. 5. Recent thromboembolic event or clinically significant cardiovascular disease. 6. Active or uncontrolled infection, including active viral hepatitis, unless protocol-defined eligibility criteria are met. 7. Known HIV infection or AIDS-related illness unless protocol-defined eligibility criteria are met. 8. History of or current drug-induced interstitial lung disease/pneumonitis, suspected interstitial lung disease (ILD)/pneumonitis, or other severe or uncontrolled chronic pulmonary disease. 9. Another malignancy within the previous 3 years, except certain malignancies with a low risk of recurrence. 10. Recent systemic corticosteroid therapy or live attenuated vaccination, except as permitted by the protocol. 11. Known hypersensitivity to DEM301 or its ingredients, or any serious medical, psychiatric, or other condition that, in the Investigator's opinion, could affect participant safety, study participation, or interpretation of study results.

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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