Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy
Pathologically-documented glioblastoma; or
Her2+ defined as 3+ on IHC
Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines52
Disqualifiers
Contraindication or history of allergic reaction to T-DXd
Significant comorbidities as per investigator evaluation
Inability to comply with protocol and/or unwilling or not available for follow up assessments or any condition which in the investigator's opinion makes the patient unsuitable for study participation
Ferrous or other contraindication to MR imaging
Trial design
Design model
Parallel
Treatments tested in this trial
Trastuzumab deruxtecan
DrugAll participants will receive T-DXd prior to indicated brain tumor resection/biopsy
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Group C: Cohort CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative plasma concentrations in brain tumors after T-DXd injections
To evaluate the brain tumor penetration of trastuzumab deruxtecan (T-DXd) and its payload (DXd) in Her2+/Her2-low/Her2-mutant brain metastases and of Her2-expressing glioblastoma. Concentrations will be presented as brain tumor:plasma ratios across brain lesions, using intraoperative plasma concentrations
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov