A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases
Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Determine the concentration of DXd in brain metastasis tumor tissue after one dose of the HER3-targeted ADC patritumab deruxtecan (HER3-DXd) administered via IV 1-3 days prior to craniotomy.
Time frame: 3 days
Secondary Endpoints
Characterize the pharmacokinetics of ADC in serum, including ADC concentration and DXd concentration, collected at screening, pre-infusion, post-infusion, 4 hours post-infusion, 24 hours after patritumab deruxtecan administration, and at craniotomy.
Assess the evidence of tumor cell death via histopathological examination and measurement of γH2AX levels in tumor tissue.
Assess the safety of patritumab deruxtecan in patients with brain metastasis after the single dose and up to 40+7 days.
Eligibility Criteria
Inclusion Criteria: 1. Participants must have newly diagnosed or recurrent brain metastases, with one of the metastases being surgically resectable. Primary tumor histology must be one of the following solid tumor types: 1. Melanoma (cutaneous skin) 2. Stomach adenocarcinoma (intestinal subtype) 3. Breast invasive carcinoma * ER+/PR+/HER2- * HER2+ (any ER/PR status) * Triple negative (ER-/PR-/HER2-) 4. Colorectal adenocarcinoma 5. Bladder Urothelial carcinoma 6. Ovarian serous cystadenocarcinoma * Serous subtype * Mucinous subtype 7. Cholangiocarcinoma 8. Prostate adenocarcinoma 9. Lung carcinoma * Non-small cell lung cancer (NSCLC) * Small cell lung cancer (SCLC) 2. Participant must be asymptomatic or minimally/well-controlled symptomatic from brain metastasis. 1. Asymptomatic is defined as free of neurologic signs and symptoms related to metastatic brain lesions and not having required or received systemic …
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