A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
NCT07691489 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-07-09
Summary
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.
Conditions
- Colorectal Cancer
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
Interventions
- DRUG
-
Fam-Trastuzumab Deruxtecan-Nxki
The 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.
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
National Institutes of Health (NIH)
collaborator NIH -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Rona Yaeger, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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