Prostatic Neoplasms

Inclusion Criteria

- Male subjects, aged >/= 18 years
- Subjects with histologically or cytologically proven
advanced castration-resistant prostate cancer (CRPC)
-- who failed at least 1 taxane regimen and are
refractory to abiraterone and/or enzalutamide therapy
OR
-- who have actively refused any treatment which would
be regarded standard.
- Subjects should have undergone bilateral orchiectomy
or should be on continuous androgen deprivation
therapy with a gonadotropin releasing hormone agonist
or antagonist.
- Subjects must have shown progressive disease after
discontinuation of anti-androgen therapy (i.e. flutamide,
bicalutamide or nilutamide) before study drug treatment.
- Total serum testosterone should be less than 50 ng/ml
or 1.7 nmol/L
- Evidence of progressive disease, defined as one or
more (Prostate Cancer Working Group 2 (PCWG2)
criteria):
- PSA level of at least 2 ng/ml that has risen on at least
2 successive occasions at least 1 week apart
- Nodal (in lymph nodes >/= 2cm) or visceral
progression as defined by Response Evaluation Criteria
in Solid Tumors (RECIST)
- Appearance of one more new lesions in bone scan
- Eastern Cooperative Oncology Group (ECOG)
performance status of 0 – 2
- Life expectancy of at least 3 months

Exclusion Criteria

- Any anticancer therapy or immunotherapy within 4 weeks of start of first dose
 - Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
 - Prior radiotherapy (local palliative radiotherapy is permitted)
 - History of allergic reactions to monoclonal antibody therapy
 - History of clinical significant cardiac disease: including  unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure ≥New York Heart Association (NYHA) Class III), and arrhythmia requiring therapy except for beta-blockers, calcium channel blockers and digoxin or uncontrolled hypertension, despite optimal medical management
 - Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT interval corrected for heart rate (QTc)-interval over 450 msec 
 - Current evidence or history of uncured (i.a. any absolute risk of latent infection) of hepatitis B or C or human immunodeficiency virus (HIV) infection
 - Chronic systemic corticosteroid therapy or any other immunosuppressive therapies should have been stopped at screening start 
 - Seizure disorder requiring therapy (such as steroids or anti-epileptics)
 - Subjects unable to inject the study drug subcutaneously for intended s.c. application
- Non-suitable for a central venous access for intended c.i.v. administration