Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT06058988
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Brain Cancer
- Glioblastoma
- Leptomeningeal Metastasis
- Metastatic Cancer
- Recurrent Glioblastoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab deruxtecan — DRUGAll participants will receive T-DXd prior to indicated brain tumor resection/biopsy
Study Details
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.
Key Dates
- Start date
- Sep 22, 2023
- Status verified
- Feb 2026
- Primary completion
- Sep 22, 2027
- Completion
- Sep 22, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort AParticipants with Her2-expressing or solid tumors with activating ERBB2 mutations with 1 or more CNS metastases requiring neurosurgical resection/biopsy with no prior T-DXd
- Experimental: Cohort BParticipants with Her2-expressing or solid tumors with activating ERBB2 mutations with 1 or more CNS metastases requiring neurosurgical resection/biopsy with no prior T-DXd and prior T-DXd exposure and with documented radiological CNS progression while on T-DXd, requiring neurosurgical resection/biopsy of 1 or more recurrent metastases, with continuation of T-DXd until prior to surgery
- Experimental: Cohort CParticipants with recurrent glioblastoma requiring neurosurgical resection/biopsy
Primary Outcome Measure
Intraoperative plasma concentrations in brain tumors after T-DXd injections [ Time Frame: Up to 24 months ]
Central Contacts
- Nelson Moss, MD212-639-7075
- Shanu Modi, MD646-888-4564
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Nelson Moss, MD 212-639-7075 |
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