NCT04616560

Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma

A Phase 2 Study of DS-8201a (NSC# 807708) in Adolescents, or Young Adults With Recurrent HER2+ Osteosarcoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effects of trastuzumab deruxtecan in treating patients with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). 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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the proportion of patients with recurrent measurable osteosarcoma treated with trastuzumab deruxtecan (DS-8201a) who are event free (%EF) at 24 weeks. SECONDARY OBJECTIVES: I. To assess the safety of DS-8201a in patients with recurrent osteosarcoma. II. To describe the pharmacokinetics of DS-8201a in patients with recurrent osteosarcoma. III. To estimate the objective response rate (ORR), event free survival (EFS), overall survival (OS) and duration of response (DOR) of patients with recurrent, measurable osteosarcoma. EXPLORATORY OBJECTIVES: I. To describe the relationship between potential biomarkers and response to DS-8201a. II. To evaluate quantitative circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and circulating tumor cells (CTCs) as a surrogate markers of response in recurrent osteosarcoma. OUTLINE: Patients receive trastuzumab deruxtecan intravenously (IV) over 30-90 minutes on day 1. Treatment repeats every 21 days for 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography or multigated acquisition scan (MUGA), blood sample collection throughout the study. After completion of study treatment, patients are followed up at 6 months.

Conditions

• Osteosarcoma
• Recurrent Osteosarcoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Echocardiography Test	Undergo echocardiography
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
BIOLOGICAL	Trastuzumab Deruxtecan	Given IV

Timeline

• Start date: 2021-03-08
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-11-05
• Last updated: 2026-04-13

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study