Recruiting nowPhase 1Randomised
| Registry number | NCT07805369 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | randomised, open label |
| Taking part | 60 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | DEM BioPharma, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug DEM301
What it is measuring
Incidence of Dose-Limiting Toxicities (DLTs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a first-in-human Phase 1 study of DEM301 in adults with previously treated advanced metastatic colorectal cancer. DEM301 is an investigational antibody-drug conjugate. The study will evaluate the safety and tolerability of DEM301, identify doses for further study, and assess how the drug behaves in the body and whether it shows signs of activity against the cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Australia.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07805369, registered by DEM BioPharma, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.