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b'Main inclusion criteria:' |
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b'Patients must be male and aged \\u226518 years.' |
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b'Patients must have histologically confirmed prostate adenocarcinoma.' |
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b'Patients must have an Eastern Cooperative Oncology Group Performance Status score of 0' |
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b'or 1.' |
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b'Specific key inclusion criteria for mCRPC patients:' |
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b'Patients must have histologically confirmed mCRPC and have progressed after at least 2' |
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b'but no more than 3 lines of life-prolonging systemic therapy (e.g., abiraterone or' |
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b'enzalutamide, docetaxel, cabazitaxel) or cannot tolerate or have refused any of these' |
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b'therapies. These lines of therapy include life-prolonging therapies administered in' |
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b'the metastatic hormone-sensitive setting.' |
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b'Prior surgical or chemical castration with a serum testosterone <1.7 nmol/L (50' |
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b'ng/dL). If the method of castration is luteinizing hormone-releasing hormone analogue' |
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b'(LHRHa), there must be a plan to maintain effective LHRHa therapy for the duration of' |
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b'the trial.' |
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b'Patients must have documented mCRPC progression within 6 months prior to screening' |
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b'(assuming no subsequent change in treatments), as determined by the investigator.' |
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b'Patients must agree to provide an archival pre-treatment formalin-fixed,' |
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b'paraffin-embedded tumor sample if available.' |
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b'Specific key inclusion criteria for newly diagnosed LPC patients:' |
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b'Treatment-na\\xefve patients with high-risk LPC (ie, N0, M0) defined according to European' |
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b'Association of Urology Guidelines on Prostate Cancer (2018). Patients must have at' |
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b'least 1 of the following:' |
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b'PSA >20 ng/mL or' |
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b'Gleason Score >7 or' |
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b'Localized stage \\u2265cT2b, N0, M0 according to tumor, node, metastasis' |
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b'classification.' |
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b'Patients who intend to have and are suitable for a radical prostatectomy.' |
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b'Patients must agree to provide tumor sample(s) from pre-treatment diagnostic biopsy' |
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b'and planned post-treatment surgery.' |
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b'Main exclusion criteria for all patients:' |
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b'Patients with uncontrolled intercurrent illness.' |
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b'Patients with a known history or current malignancy other than the inclusion' |
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b'diagnosis. Note: Patients with non-invasive basal cell or squamous cell skin' |
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b'carcinoma, non-invasive, superficial bladder cancer, and any cancer with a complete' |
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b'response (CR) that lasted more than 2 years may be included.' |
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b'Patients who have had major surgery (e.g., requiring general anesthesia) within 4' |
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b'weeks before screening, or have not fully recovered from surgery, or have a surgery' |
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b'planned during the time of trial participation, except for the radical prostatectomy' |
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b'planned for patients in Part 2 Arms 2 and 3.' |
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b'Patients who have a known history of any of the following (testing not required):' |
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b'Human immunodeficiency virus (HIV) 1 or 2' |
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b'Hepatitis B (carrier or active infection)' |
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b'Hepatitis C (unless considered cured 5 years post curative anti-viral therapy)' |
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b'Patients who have received or currently receive the following therapy/medication:' |
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b'Chronic systemic immunosuppressive corticosteroid treatment (prednisone >5 mg' |
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b'daily orally [PO] or IV, or equivalent) during the trial. Note: Replacement' |
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b'therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or' |
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b'pituitary insufficiency) is not considered a form of systemic treatment and is' |
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b'permitted.' |
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b'Prior treatment with other immune modulating agents for any non-cancer disease' |
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b'within 4 weeks or 5 half-lives of the agent (whichever is shorter) before the' |
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b'first dose of investigational medicinal product (IMP).' |
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b'Prior treatment with live-attenuated vaccines within 4 weeks before the first' |
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b'dose of IMP during treatment, and for 3 months after the last dose of W_pro1.' |
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b'Prior treatment with an investigational drug (including investigational vaccines)' |
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b'within 4 weeks or 5 half-lives of the agent (whichever is shorter) before the' |
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b'planned first dose of IMP.' |
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b'Therapeutic PO or IV antibiotics within 14 days prior to enrollment. Note:' |
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b'Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary' |
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b'tract infection or chronic obstructive pulmonary disease) may be enrolled.' |
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b'Concurrent use of herbal products that may decrease PSA levels (e.g., saw' |
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b'palmetto).' |
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b'Specific key exclusion criteria for mCRPC patients:' |
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b'Excluded medical conditions' |
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b'Patients with toxicities from previous anti-cancer therapies that have not resolved to' |
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b'baseline levels or to Grade 1 or less according to National Cancer Institute (NCI)' |
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b'Common Terminology Criteria for Adverse Events (CTCAE) v5.0 with the exception of' |
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b'alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral' |
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b'neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must' |
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b'have recovered to \\u2264Grade 2.' |
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b'Patients with clinically active brain metastases.' |
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b'Patients with a history of symptomatic metastatic brain or meningeal tumors may' |
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b'be included, if the end of definitive therapy is >3 months before the first dose' |
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b'of W_pro1 and the patients have no clinical or radiological evidence of tumor' |
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b'growth.' |
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b'Patients with brain metastases must not be undergoing acute or chronic' |
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b'corticosteroid therapy or steroid taper.' |
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b'Patients with central nervous system symptoms should undergo a computed' |
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b'tomography scan or magnetic resonance imaging (MRI) of the brain to exclude new' |
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b'or progressive brain metastases. Spinal cord metastasis is acceptable. However,' |
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b'patients with spinal cord compression should be excluded.' |
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b'Excluded prior or concomitant anti-cancer therapies' |
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b'Patients who have received or currently receive the following anti-cancer' |
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b'therapy/agent:' |
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b'Prior radiation therapy with curative intent within 14 days before the first dose' |
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b'of IMP. Note: Palliative radiotherapy is allowed.' |
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b'Prior treatment with an anti-cancer agent (within 4 weeks or for systemic' |
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b'therapies after at least 5 half-lives of the drug [whichever is shorter] before' |
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b'the first dose of IMP). Note: Prior treatment with bone resorptive therapy, such' |
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b'as bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab, is' |
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b'allowed assuming that the patients have been on stable doses for \\u22654 weeks prior' |
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b'to first dose of trial treatment.' |
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b'Prior treatment with anti-cancer immunomodulating agents, such as blockers of' |
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b'PD-1, programmed cell death 1 ligand 1 (PD-L1), tumor necrosis factor receptor' |
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b'uperfamily member 9 (TNRSF9, 4-1BB, CD137), tumor necrosis factor receptor' |
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b'uperfamily member 4 (OX-40), therapeutic vaccines, cytokine treatments, or any' |
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b'investigational agent within 4 weeks before the first dose of IMP.' |
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