Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

INCLUSION CRITERIA:

Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
Male patient with mCRPC with measurable or evaluable disease
Patient should have failed at least 1 line of taxane-based chemotherapy
Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor
Patients with evidence of progressive disease
Predicted life-expectancy of ≥ 6 months.
ECOG performance status of 0 or 1.

Males who are:

Surgically sterile
Compliant with an effective contraceptive regimen (i.e. use of male condom with female partner and assuring use of an additional highly effective contraceptive method with a failure rate
Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures

EXCLUSION CRITERIA

Uncontrolled or severe intercurrent medical condition.
Patient has any active-, uncontrolled-, or suspected infection.
Known clinically relevant immunodeficiency disorders.
Unstable cardiovascular function
Previous treatment with an aminobisphosphonate IV (e.g. ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
Known ongoing drug and alcohol abuse in the opinion of the investigator.