A Phase I/II Study of HE3235 in Patients With Prostate Cancer

Main Inclusion Criteria:

* Patient is male and at least 18 years of age, at the time of screening;
* Patient has metastatic disease (any T, any N, M1);
* Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naïve
* Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
* Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:

  * PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
  * Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria;
  * Progression of metastatic bone disease on bone scan with \> 2 new lesions
* Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;

Main Exclusion Criteria:

* Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed
* Patient has active infection;
* Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities;
* Patient who has any clinically significant abnormalities in laboratory results at screening
* Patient who has a history of clinically significant neurological or psychiatric condition;

Additional criteria are applicable to expansion cohorts.