Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06058988

Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-23

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to find out how much tratuzumab deruxtecan (T-DXd) can penetrate the tumor when injected into the body, and whether T-DXd may be an effective treatment for brain cancers that express the HER2 protein.

CONDITIONS

Official Title

Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older with one or more brain tumors planned for neurosurgical resection or biopsy
  • Pathologically documented glioblastoma or metastatic cancer with HER2 expression or activating HER2 mutation
  • HER2-positive defined as 3+ on immunohistochemistry (IHC)
  • HER2-low defined as IHC 1+ or 2+ and in situ hybridization negative per ASCO-CAP 2018 guidelines
  • Activating HER2 mutations at known hotspots or involving key HER2 domains
  • Untreated brain tumors allowed; prior radiation including whole-brain or stereotactic radiation permitted
  • Patients with leptomeningeal metastasis eligible if parenchymal brain tumor requires surgery
  • Cohorts include patients with and without prior T-DXd exposure and recurrent glioblastoma
  • No limit on prior CNS radiation or systemic therapy including HER2-targeted antibodies
  • Karnofsky Performance Status (KPS) ≥ 60 or ECOG performance status < 2
  • Life expectancy greater than 12 weeks
  • Left ventricular ejection fraction ≥ 50%
  • Adequate bone marrow, renal, liver, and coagulation function within 7 days prior to treatment
  • Negative pregnancy test for women of childbearing potential and use of effective contraception
  • Agreement to avoid breastfeeding during and for 7 months after treatment
  • Male patients with female partners of childbearing potential must use contraception and avoid fathering a child from enrollment until 4 months post-treatment
  • Adequate washout from prior therapies to recover from toxicities as judged by investigator
Not Eligible

You will not qualify if you...

  • Allergy or history of hypersensitivity to trastuzumab deruxtecan (T-DXd) or similar monoclonal antibodies
  • Significant other medical conditions as judged by the investigator
  • Inability or unwillingness to comply with the study protocol or follow-up
  • Contraindications to MRI or ferrous implants
  • Recent myocardial infarction within 6 months
  • Symptomatic congestive heart failure (NYHA Class II-IV)
  • Prolonged QT interval above specified limits
  • Elevated troponin without cardiac symptoms without cardiology clearance
  • History or current interstitial lung disease or pneumonitis requiring steroids
  • Significant lung diseases or autoimmune disorders affecting lungs
  • Complete pneumonectomy
  • Uncontrolled infections requiring intravenous treatment
  • Active HIV or hepatitis B or C infections (except HCV antibody positive but RNA negative)
  • Receipt of live attenuated vaccine within 30 days prior to treatment or planned during study
  • Unresolved toxicities from prior cancer therapy above Grade 1, except stable chronic Grade 2 toxicities
  • Pregnancy or breastfeeding
  • Severe allergies to study drug components
  • History of severe hypersensitivity to other monoclonal antibodies
  • Patients with substance abuse or other conditions interfering with study participation
  • Multiple primary cancers within 3 years except certain adequately treated cancers
  • Presence of pleural, pericardial, or abdominal effusions requiring drainage or specific therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

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Research Team

N

Nelson Moss, MD

CONTACT

S

Shanu Modi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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