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PEPN1924 - A Phase 1/2 study of DS-8201a (NSC# 807708, IND# 153036) in children, adolescents, or young adults with recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

Status: Recruiting

This phase II trial studies the effects of trastuzumab deruxtecan in treating patients (> 12 years and ≤ 39 years of age) with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them.

I'm interested

Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• children, adolescents, and young adults with Wilms tumor or desmoplastic small round cell tumor (DSRCT)
• disease that has returned after treatment or has not responded to standard treatment
• measurable tumor that can be evaluated during the study
• recovered from previous cancer treatment and meet study health requirements
• see the ClinicalTrials.gov listing for complete inclusion criteria
Exclusion Criteria:

• currently receiving another investigational treatment or anti-cancer therapy
• previous treatment with certain HER2-targeted therapies
• previous solid organ transplant
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
Interventions:

Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Biological: Trastuzumab Deruxtecan

Conditions:

Cancer

Keywords:

bone cancer, DSRCT, HER2+ Osteosarcoma, Wilms tumor

Study Contact: Mollie Koppes - thom1031@umn.edu
Principal Investigator: Robin Williams
Phase: PHASE1
IRB Number: SITE00001108
See this study on ClinicalTrials.gov

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