A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is find out whether the combination of trastuzumab deruxtecan (T-DXd) and cetuximab is an effective treatment for participants with metastatic and/or unresectable colorectal cancer that expresses low levels of HER2 and that has gotten worse after receiving standard treatment.
Eligibility criteria
Qualifiers
Have histologically confirmed adenocarcinoma of the colon or rectum that is metastatic and/or unresectable.
Unless otherwise contraindicated, participants must have received regimens containing the following agents: fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, and if the tumor is MSI-H/MMRd, a PD-(L)1 directed antibody. There is no maximum number of prior lines of therapy.
Prior anti-HER2 therapies other than T-DXd are allowed, with a washout period of at least 4 weeks.
Prior anti-EGFR therapies, including cetuximab, are allowed, with a washout period of at least 4 weeks.
Disqualifiers
Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Previous enrollment in the present study.
Currently participating in another interventional clinical trial.
History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE v5.0 ≥ Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
Trial design
Treatments tested in this trial
- Fam-Trastuzumab Deruxtecan-Nxki
Treatment groups
27 Participants
are divided into 2 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
AstraZeneca
Collaborator
Eli Lilly and Company
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov