A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07691489
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fam-Trastuzumab Deruxtecan-Nxki — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In
    This study will begin with a Safety Lead-In of 6-18 participants to assess safety/tolerability of this novel combination and to determine the RP2D.
  • Experimental: Expansion Cohort
    If at least 1 out of 13 participants in the first stage has a complete or partial response (CR/PR), an additional 14 participants will be enrolled.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)CommackNew York11725
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Rona Yaeger, MD
646-888-5109
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)UniondaleNew York11553
Rona Yaeger, MD
646-888-5109

Find similar trials in Basking Ridge, NJ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering at Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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