Clinical trialNCT04616560RecruitingPhase 1/PHASE2Interventional

Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

SponsorNational Cancer Institute (NCI)Enrollment55Desmoplastic Small Round Cell TumorOsteosarcomaRecurrent Desmoplastic Small Round Cell TumorRecurrent Kidney Wilms TumorRecurrent OsteosarcomaRefractory Desmoplastic Small Round Cell Tumor+2 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Damon R Reed
Pediatric Early Phase Clinical Trial Network
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Suspended
Children'S Hospital Los Angeles
Los Angeles, California, United States
Fariba Navid
Recruiting
Children'S Hospital of Orange County
Orange, California, United States
Suspended
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
Lianna J. Marks
Recruiting
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Suspended
Children'S Hospital Colorado
Aurora, Colorado, United States
Suspended
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Suspended
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Suspended
Children'S Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Jason R. Fangusaro
Recruiting
Lurie Children'S Hospital-Chicago
Chicago, Illinois, United States
Suspended
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Ami V. Desai
Recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Suspended
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Christine A. Pratilas
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Suspended
C S Mott Children'S Hospital
Ann Arbor, Michigan, United States
Rajen Mody
Recruiting
University of Minnesota/masonic Cancer Center
Minneapolis, Minnesota, United States
Suspended
Children'S Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Suspended
Washington University School of Medicine
St Louis, Missouri, United States
Shalini Shenoy
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Emily K. Slotkin
Recruiting
Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center
New York, New York, United States
Suspended
Duke University Medical Center
Durham, North Carolina, United States
Jessica M. Sun
Recruiting
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Suspended
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Theodore W. Laetsch
Recruiting
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Suspended
Saint Jude Children'S Research Hospital
Memphis, Tennessee, United States
Jessica Gartrell
Recruiting
Vanderbilt University/ingram Cancer Center
Nashville, Tennessee, United States
Active, not recruiting
Ut Southwestern/simmons Cancer Center-Dallas
Dallas, Texas, United States
Suspended
Baylor College of Medicine/dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Active, not recruiting
Primary Children'S Hospital
Salt Lake City, Utah, United States
Suspended

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Trastuzumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Mar 2021
Primary completion: 31 Dec 2027
Completion: 31 Dec 2027
Last update posted: 10 Aug 2026
Registered enrollment: 55
Registry id: NCT04616560

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.