Phase 1 study for people with Colorectal Cancer
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Clinical Site 101 | Nedlands | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 15 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.