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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Fam-Trastuzumab Deruxtecan-Nxki
DrugThe investigational study drug, fam-trastuzumab deruxtecan-nxki (ENHERTU® ), consists of an antibody component, MAAL-9001, covalently conjugated via a maleimide tetrapeptide linker, to a drug component, MAAA-1181a.
Treatment groups
27 Participants
are divided into 2 treatment groupsGroup A: Safety Lead-InExperimental treatment 1 intervention
Group B: Expansion CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
To determine the objective response rate (ORR), as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, of T-DXd + cetuximab in participants with HER2-low mCRC that has progressed on standard therapies.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
AstraZeneca
Collaborator
Eli Lilly and Company
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
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