A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer

Exclusion Criteria

• •Subjects with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer.
• •The subject has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of investigational product, with the following modifications:
• •1. At least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide
• •2. At least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy
• •3. At least 28 days before the first dose of investigational product since completion of treatment with Radium-223.
• •4. At least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment.
• •NOTE: An LHRH agonist or antagonist required for ongoing testosterone suppression will be permitted if Inclusion Criterion is satisfied.
• •Prior exposure to PSMA-directed therapies.
• •Subjects with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if:
• •1. More than 25% of marrow-bearing bone has been irradiated.
• •2. The last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of investigational product.
• •Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to the first dose of investigational product.
• •Subjects with known history of peripheral vasculopathies including, but not limited to, macro and microangiopathies secondary to diabetes, peripheral arteriopathy of any cause, intermittent claudication, repeated and/or non-healing ulcers of any cause.