Can a targeted drug conjugate outsmart advanced colorectal cancer?
NCT ID NCT07805369
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 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.
Show the full entry requirements Hide 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.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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