A Phase 1 Study of DEM301 in Participants With Metastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDEM BioPharma, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
DEM301
DrugDEM301 is an investigational antibody-drug conjugate being evaluated as monotherapy in Dose Escalation and Dose Expansion cohorts.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of DLTs in DLT-evaluable participants enrolled in Dose Escalation.
Time frame
21 Days2
Incidence of Adverse Events (AEs)
Incidence of AEs, including events requiring dose interruption or discontinuation, in participants enrolled in Dose Escalation and Dose Expansion.
Time frame
From first dose through 30 days after the last dose, up to approximately 24 months3
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.
Time frame
From signing informed consent through 30 days after the last dose, up to approximately 24 monthsSecondary outcomes
1
Maximum Tolerated Dose (MTD) of DEM301, if Applicable
The MTD of DEM301, if applicable, will be determined based on available Dose Escalation data.
Time frame
At completion of Dose Escalation, approximately 12 months2
Recommended Dose(s) for Expansion (RDEs) of DEM301
One or more recommended doses for expansion will be selected based on available Dose Escalation data.
Time frame
At completion of Dose Escalation, approximately 12 months3
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.
Time frame
12 weeks4
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.
Time frame
Up to approximately 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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