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

Active:	Yes
Cancer Type:	Sarcoma	NCT ID:	NCT04616560
Trial Phases:	Phase II	Protocol IDs:	PEPN1924 (primary) NCI-2020-08428 PEPN1924
Eligibility:	12 - 39 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Pediatric Early Phase Clinical Trial Network
NCI Full Details:	http://clinicaltrials.gov/show/NCT04616560

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 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.

Objectives

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.

After completion of study treatment, patients are followed up at 6 months.

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