First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer

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