Metastatic Colorectal CancerPhase 1NCT07805369
A Phase 1 Study of DEM301 in Participants With Metastatic Colorectal Cancer
A Phase 1 study testing DEM301 in people with Metastatic Colorectal Cancer and Colon Cancer, run by DEM BioPharma, Inc. at 2 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- DEM301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- 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.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Have at least 1 measurable lesion at baseline suitable for repeat imaging evaluation by RECIST v1.1.
- Adequate bone marrow, liver, kidney, and coagulation function per protocol requirements.
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- 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.
- Female participants must not be pregnant or breastfeeding. Male and female participants must comply with protocol-defined reproductive and contraception requirements.
- Have suitable venous access for study treatment and required blood sampling.
- Be willing and able to comply with study assessments, schedule, and restrictions.
- Written informed consent must be obtained before any study-related procedures are performed.
Who cannot join
- Prior treatment with certain antibody-drug conjugates, as defined in the protocol. Protocol-defined exceptions may apply.
- Recent anticancer therapy, investigational treatment, major surgery, or radiation therapy within the protocol-defined washout periods.
- Ongoing clinically significant toxicity from prior therapy that has not recovered to the protocol-required level.
- Active central nervous system (CNS) metastases or suspected or confirmed leptomeningeal disease. Participants with treated and stable brain metastases may be eligible.
- Recent thromboembolic event or clinically significant cardiovascular disease.
- Active or uncontrolled infection, including active viral hepatitis, unless protocol-defined eligibility criteria are met.
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- Known HIV infection or AIDS-related illness unless protocol-defined eligibility criteria are met.
- History of or current drug-induced interstitial lung disease/pneumonitis, suspected interstitial lung disease (ILD)/pneumonitis, or other severe or uncontrolled chronic pulmonary disease.
- Another malignancy within the previous 3 years, except certain malignancies with a low risk of recurrence.
- Recent systemic corticosteroid therapy or live attenuated vaccination, except as permitted by the protocol.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Clinical Site 104
Birtinya, Queensland, 4575
- Recruiting
Clinical Site 101
Nedlands, Western Australia, 6009
About this study
Official title: A Phase 1, Open-Label, Two-Part (Dose Escalation and Expansion) Study of DEM301 in Participants With Select Advanced Solid Tumors
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.
Read the detailed description
This is a Phase 1, multicenter, open-label study of DEM301 in participants with previously treated advanced metastatic colorectal cancer. The study has two parts: Dose Escalation, and Dose Expansion.
Dose Escalation will evaluate the safety and tolerability of DEM301 and identify one or more recommended doses for further study. Dose Expansion will further evaluate DEM301 at the selected dose or doses.
The study will also assess preliminary antitumor activity, pharmacokinetics, immunogenicity, pharmacodynamic effects, and exploratory biomarkers. Approximately 60 participants are planned.
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- DEM301
- Keywords
- DEM301, antibody-drug conjugate (ADC), ADC, metastatic colorectal cancer (mCRC), mCRC, colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEM301Drug
DEM301 is an investigational antibody-drug conjugate being evaluated as monotherapy in Dose Escalation and Dose Expansion cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will receive DEM301 in sequential Dose Escalation cohorts to evaluate safety and identify doses for further study. Receives: Drug: DEM301 |
| Dose Expansion | Experimental | Participants will receive DEM301 at a recommended dose selected based on data from Dose Escalation. Receives: Drug: DEM301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of DLTs in DLT-evaluable participants enrolled in Dose Escalation.
Measured: 21 Days
Incidence of Adverse Events (AEs)
Incidence of AEs, including events requiring dose interruption or discontinuation, in participants enrolled in Dose Escalation and Dose Expansion.
Measured: From first dose through 30 days after the last dose, up to approximately 24 months
Incidence of Serious Adverse Events (SAEs)
Incidence of SAEs in participants enrolled in Dose Escalation and Dose Expansion. Related SAEs occurring after the End of Treatment visit will also be reported according to the protocol.
Measured: From signing informed consent through 30 days after the last dose, up to approximately 24 months
Secondary outcomes (11)
Maximum Tolerated Dose (MTD) of DEM301, if Applicable
The MTD of DEM301, if applicable, will be determined based on available Dose Escalation data.
Measured: At completion of Dose Escalation, approximately 12 months
Recommended Dose(s) for Expansion (RDEs) of DEM301
One or more recommended doses for expansion will be selected based on available Dose Escalation data.
Measured: At completion of Dose Escalation, approximately 12 months
Objective Response Rate (ORR) at 12 Weeks
ORR at 12 weeks will be assessed according to RECIST v1.1 in response-evaluable participants in Dose Escalation and Dose Expansion.
Measured: 12 weeks
Duration of Response (DoR)
Duration of response will be evaluated according to RECIST v1.1 in participants with a documented response in Dose Escalation and Dose Expansion.
Measured: Up to approximately 24 months
Disease Control Rate (DCR) at 12 Weeks
DCR at 12 weeks will be assessed according to RECIST v1.1 in response-evaluable participants in Dose Escalation and Dose Expansion.
Measured: 12 Weeks
Progression-Free Survival (PFS) at 12 Weeks
PFS at 12 weeks will be evaluated in response-evaluable participants in Dose Escalation and Dose Expansion.
Measured: 12 Weeks
Overall Survival (OS) at 24 Weeks
OS at 24 weeks will be evaluated in participants in Dose Escalation and Dose Expansion.
Measured: 24 Weeks
Area Under the Concentration-Time Curve (AUC) of DEM301 and Protocol-Specified Analytes
AUC will be characterized for DEM301 and protocol-specified analytes in participants in Dose Escalation and Dose Expansion.
Measured: At protocol-specified pharmacokinetics (PK) sampling time points, up to approximately 24 months
Terminal Elimination Half-Life (t½) of DEM301 and Protocol-Specified Analytes
Terminal elimination half-life will be characterized for DEM301 and protocol-specified analytes in participants in Dose Escalation and Dose Expansion.
Measured: At protocol-specified PK sampling time points, up to approximately 24 months
Maximum Concentration (Cmax) of DEM301 and Protocol-Specified Analytes
Maximum concentration will be characterized for DEM301 and protocol-specified analytes in participants in Dose Escalation and Dose Expansion.
Measured: At protocol-specified PK sampling time points, up to approximately 24 months
Immunogenicity of DEM301
The presence of anti-drug antibodies and neutralizing antibodies will be evaluated in participants in Dose Escalation and Dose Expansion.
Measured: At protocol-specified PK sampling time points, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study consists of sequential Dose Escalation and Dose Expansion components. DEM301 will initially be evaluated in dose escalation cohorts. Based on available study data, one or more recommended doses will be selected for further evaluation in Dose Expansion.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DEM BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805369
- Sponsor's protocol ID
- DEM301-01
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Part (Dose Escalation and Expansion) Study of DEM301 in Participants With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07805369
- Acronym / sponsor ID
- DEM301-01
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Keywords
- DEM301, antibody-drug conjugate (ADC), ADC, metastatic colorectal cancer (mCRC), mCRC, colon cancer, rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- DEM BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, multicenter, open-label study of DEM301 in participants with previously treated advanced metastatic colorectal cancer. The study has two parts: Dose Escalation, and Dose Expansion.
Dose Escalation will evaluate the safety and tolerability of DEM301 and identify one or more recommended doses for further study. Dose Expansion will further evaluate DEM301 at the selected dose or doses.
The study will also assess preliminary antitumor activity, pharmacokinetics, immunogenicity, pharmacodynamic effects, and exploratory biomarkers. Approximately 60 participants are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of sequential Dose Escalation and Dose Expansion components. DEM301 will initially be evaluated in dose escalation cohorts. Based on available study data, one or more recommended doses will be selected for further evaluation in Dose Expansion.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: DEM301Participants will receive DEM301 in sequential Dose Escalation cohorts to evaluate safety and identify doses for further study. |
| Dose Expansion | Experimental | Drug: DEM301Participants will receive DEM301 at a recommended dose selected based on data from Dose Escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years.
- 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.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Have at least 1 measurable lesion at baseline suitable for repeat imaging evaluation by RECIST v1.1.
Key exclusion criteria (11 listed)
- Prior treatment with certain antibody-drug conjugates, as defined in the protocol. Protocol-defined exceptions may apply.
- Recent anticancer therapy, investigational treatment, major surgery, or radiation therapy within the protocol-defined washout periods.
- Ongoing clinically significant toxicity from prior therapy that has not recovered to the protocol-required level.
- Active central nervous system (CNS) metastases or suspected or confirmed leptomeningeal disease. Participants with treated and stable brain metastases may be eligible.
- Recent thromboembolic event or clinically significant cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEM301DEM301 is an investigational antibody-drug conjugate being evaluated as monotherapy in Dose Escalation and Dose Expansion cohorts. | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 21 Days
Incidence of DLTs in DLT-evaluable participants enrolled in Dose Escalation.
Incidence of Adverse Events (AEs)
Time frame: From first dose through 30 days after the last dose, up to approximately 24 months
Incidence of AEs, including events requiring dose interruption or discontinuation, in participants enrolled in Dose Escalation and Dose Expansion.
Incidence of Serious Adverse Events (SAEs)
Time frame: From signing informed consent through 30 days after the last dose, up to approximately 24 months
Incidence of SAEs in participants enrolled in Dose Escalation and Dose Expansion. Related SAEs occurring after the End of Treatment visit will also be reported according to the protocol.
11 secondary outcomes
Maximum Tolerated Dose (MTD) of DEM301, if Applicable
Time frame: At completion of Dose Escalation, approximately 12 months
Recommended Dose(s) for Expansion (RDEs) of DEM301
Time frame: At completion of Dose Escalation, approximately 12 months
Objective Response Rate (ORR) at 12 Weeks
Time frame: 12 weeks
Duration of Response (DoR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) at 12 Weeks
Time frame: 12 Weeks
Progression-Free Survival (PFS) at 12 Weeks
Time frame: 12 Weeks
Overall Survival (OS) at 24 Weeks
Time frame: 24 Weeks
Area Under the Concentration-Time Curve (AUC) of DEM301 and Protocol-Specified Analytes
Time frame: At protocol-specified pharmacokinetics (PK) sampling time points, up to approximately 24 months
Terminal Elimination Half-Life (t½) of DEM301 and Protocol-Specified Analytes
Time frame: At protocol-specified PK sampling time points, up to approximately 24 months
Maximum Concentration (Cmax) of DEM301 and Protocol-Specified Analytes
Time frame: At protocol-specified PK sampling time points, up to approximately 24 months
Immunogenicity of DEM301
Time frame: At protocol-specified PK sampling time points, up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DEM301 in people with Metastatic Colorectal Cancer and Colon Cancer, run by DEM BioPharma, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DEM301 Study Team (857-242-1002, clinicaltrials@dembiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: 21 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.