OncoMatch/Clinical Trials/NCT06058988
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Is NCT06058988 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trastuzumab deruxtecan for brain cancer.
Treatment: Trastuzumab deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
Her2+ defined as 3+ on IHC
Required: HER2 (ERBB2) low expression (IHC 1+ or 2+ and ISH-)
Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines
Required: HER2 (ERBB2) activating mutation
Her2 mutations must be described to be activating, occur at a known hotspot (e.g. exon 20 insertions, S310, G660, R678, L755, D769, L777), or involve the transmembrane, juxtamembrane or tyrosine kinase domains
Disease stage
Metastatic disease required
Metastatic Cancer
Prior therapy
Cannot have received: antibody-drug conjugate (trastuzumab deruxtecan)
Exception: Cohort A: T-DXd naïve; Cohort B: prior T-DXd exposure
Cohort A: ...no prior T-DXd exposure (T-DXd naïve); Cohort B: ...with prior T-DXd exposure
Lab requirements
Blood counts
ANC ≥1.5 × 10^3/μL (no G-CSF within 1 week prior to C1D1); Platelet count ≥10.0x10^4/μL (no ongoing transfusions or growth factor support, no platelet transfusion within 1 week prior to C1D1); Hemoglobin ≥ 8.0 g/dL (no ongoing transfusions or growth factor support, no RBC transfusion within 1 week prior to C1D1); Serum albumin ≥ 2.5 g/dL
Kidney function
Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation
Liver function
AST and ALT ≤3 × ULN (<5x ULN in participants with liver metastases); total bilirubin ≤1.5 × ULN if no liver metastases or <3 × ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline
Cardiac function
Left ventricular ejection fraction ≥50%
Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment): ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, New York
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