Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04294628
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the biological effects of DS-8201a on patients with HER2 positive cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). DS-8201a works by binding to a protein called HER2 that is present on the surface of tumor cells. This allows DS-8201a to kill the tumor cells by damaging their deoxyribonucleic acid (DNA), resulting in tumor cell death. This study looks at how DS-8201a may affect the levels of certain proteins and immune cells in tumors and how well the drug works against tumor cells by examining cells from a small piece tumor taken before and after DS-8201a is given.

Key Dates

Start date
Sep 1, 2020
Status verified
Jan 2026
Primary completion
Sep 2, 2025
Completion
Jan 19, 2027

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trastuzumab deruxtecan)
    Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, CT or MRI, biopsies, and collection of blood samples throughout the study.

Primary Outcome Measure

Total topoisomerase 1 (Top1) [ Time Frame: Up to day 1 of cycle 3 (each cycle is 21 days) or optionally, up to time of disease progression or restaging follow-up ]

Locations (6)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Bethesda, MD

By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MDDana-Farber Cancer Institute· Boston, MANYP/Weill Cornell Medical Center· New York, NYOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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