BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)

Inclusion criteria

• The patient has histologically, or cytologically, confirmed adenocarcinoma of the prostate.
• Male patient aged, equal to, or more than,18 years old.
• Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2). Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days before the start of study treatment.
• Patients with a prostate serum antigen (PSA), equal to, or more than, 5 nanograms per mililiter (ng/mL).
• Patients with prior surgical or chemical castration with a serum testosterone of 50% as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA).
• Absolute neutrophil count (ANC) >=1500/microlitre (uL).
• Haemoglobin >=9 gram per deciliter (g/dL).
• Platelets >=100,000/uL.
• Bilirubin 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
• Patients with small cell or neuroendocrine tumours.
• Patients with known or suspected leptomeningeal metastases.
• Uncontrolled or poorly controlled hypertension.
• Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
• Patients with epilepsy, seizures, or predisposing factors for seizure as judged by the investigator.
• Patients unable to comply with the protocol as judged by the investigator.
• Active alcohol or active drug abuse as judged by the investigator.
• A history of allergy to human monoclonal antibodies.
• Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
• Previous or concomitant malignancies at any other site with the exception of the following:
• benign basal cell carcinoma
• benign low grade transitional cell carcinoma of the bladder
• other effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured
• Only for patients entering phase Ib dose escalation and phase II cohorts:
• Patients who have received more than 2 prior non-docetaxel containing cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
• Patients who have received a taxane based treatment or abiraterone, within 4 weeks before start of study treatment.
• Patients that have received prior enzalutamide in any setting will not be eligible.

Exclusion criterion only for patients entering phase Ib expansion cohort:

• Patients that have received prior taxane-based chemotherapy or abiraterone in any setting will not be eligible for the expansion cohort.

Additional exclusion criterion for patients undergoing tumour biopsy:

• For patients that are to undergo the tumour biopsy, a history of a hereditary bleeding disorder, or clinically relevant major bleeding event in the past 6 months, as judged by the investigator.
• Further exclusion criteria apply