HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease
Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors
Sponsor: MedSIR + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Efficacy: Local determination of intracranial objective response rate (ORR-IC) in cohort 1 and cohort 2.
Time frame: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months
Efficacy: Overall survival (OS) rate at 3 months in cohort 3.
Time frame: From baseline up to 3 months
Secondary Endpoints
Efficacy: Central determination of ORR in cohort 1, cohort 2, and cohort 3.
Efficacy: progression-free survival (PFS) in cohort 1, cohort 2, and cohort 3.
Efficacy: bicompartmental clinical benefit rate (CBR) in cohort 1, cohort 2, and cohort 3.
Eligibility Criteria
GENERAL INCLUSION CRITERIA (Patients will be included in the study only if they meet all the following inclusion criteria): 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Age ≥ 18 years at the time of signing ICF. 3. Life expectancy ≥ 6 weeks. 4. Karnofsky Performance Status (KPS) ≥70%, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. 5. Patient must be able to tolerate therapy. 6. Availability and willingness to provide the most recently available tumor tissue sample (formalin-fixed and paraffin-embedded \[FFPE\], no cytology/cell block, no bone/decalcified bone sample) of primary tumor or any metastatic site from biopsy collected after last round of prior treatment and ≤ 6 months prior to HER3-DXd, if possible, at the time of inclusion for retrospective exploratory biomarker testing. If archival tissue is not available, a newly obtained bas…
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