N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 ClinicalTrials.gov

A Phase 1 Study of DEM301 in Participants With Metastatic Colorectal Cancer

Sponsor: DEM BioPharma, Inc. • ClinicalTrials.gov ID: NCT07805369

Registry updated: 2026-10-15
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • DEM301 (Drug)
    DEM301 is an investigational antibody-drug conjugate being evaluated as monotherapy in Dose Escalation and Dose Expansion cohorts.

Eligibility criteria

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.

Conditions

Metastatic Colorectal Cancer Colon Cancer Rectal Cancer

Locations

  • Clinical Site 101 — Nedlands, Western Australia, Australia
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record