Phase 1 of EC1169 In Patients With Recurrent MCRPC

The purpose of this study is to determine the safety of EC1169 and the best dose to use in humans with recurrent Metastatic, Castration-Resistant Prostate Cancer (mCRPC). This study will also determine how EC1169 is distributed, broken down, passed and absorbed through your body and how quickly it is eliminated (leaves the body). All patients will receive EC1169.

Study phase: I

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Male

Patients must be males ? 18 years of age

Patients must have histological, pathological and/or cytological confirmation of prostate cancer

Patients must have progressive mCRPC defined by meeting at least one of the following criteria:
PSA progression defined as 25% increase over a baseline value of > 2 ng/ml with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval. Baseline is defined as the PSA nadir level since commencing most recent prior therapy

Soft-tissue progression defined as an increase ? 20% in the sum of the diameter (SOD; short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD, or the appearance of one or more new lesions, since the onset of the most recent prior therapy

Progression of bone disease according to PCWG3 criteria

Patients must have a castrate level of serum testosterone (< 50 ng/dL)

Primary disease category: Cancer

Sponsor: Endocyte, Inc

Projected enrollment dates: January 2017 to January 2018

Official study title: A Phase 1 Study Of A Prostate-Specific Membrane Antigen Targeting-Tubulysin Conjugate EC1169 In Patients With Recurrent Metastatic, Castration-Resistant Prostate Cancer (mCRPC)