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Monoclonal Antibodies

Treatment (trastuzumab deruxtecan) for Osteosarcoma

Phase 2
Waitlist Available
Led By Damon R Reed
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Eligible Conditions
  • Osteosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival of DS-8201A for HER2+ osteosarcoma
Secondary study objectives
Duration of response
Event free survival of DS-8201A for HER2+ osteosarcoma
Incidence of adverse events of DS-8201A for HER2+ osteosarcoma
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan)Experimental Treatment1 Intervention
Patients receive trastuzumab deruxtecan 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,840 Previous Clinical Trials
41,002,795 Total Patients Enrolled
104 Trials studying Osteosarcoma
16,601 Patients Enrolled for Osteosarcoma
Damon R ReedPrincipal InvestigatorPediatric Early Phase Clinical Trial Network
~3 spots leftby Mar 2025
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