Study of HPN424 in Patients With Advanced Prostate Cancer
Advanced Prostate Cancer
About this trial
This is an interventional treatment trial for Advanced Prostate Cancer focused on measuring Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Harpoon, TriTAC
Eligibility Criteria
Key Inclusion Criteria:
- Male patients ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
Progressive metastatic castrate-resistant prostate cancer (mCRPC):
- Serum testosterone levels less than 50 ng/dL (or ≤0.50 ng/mL or 1.73 nmol/L) within 28 days prior to start of study drug
- Radiographic evidence of metastatic disease
- Disease progression on the prior systemic regimen
- Must have received at least 2 prior systemic therapies approved for mCRPC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function
- Able to read, understand and provide written informed consent
Key Exclusion Criteria:
- Previously treated or current brain metastases
- Untreated spinal cord compression. Participants must be neurologically stable off steroids for at least 4 weeks prior to first dose of study drug
- Concurrent treatment with anti-tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to first dose of study drug
- History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed)
- History of clinically significant cardiovascular disease such as symptomatic congestive heart failure (CHF), myocardial infarction within 6 months before first dose of study drug, history of thromboembolic event within 3 months before first dose of study drug
- Known active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen (HBsAg) positivity and/or anti-hepatitis C virus (HCV) positivity, respectively, or known history of human immunodeficiency virus (HIV) seropositive status
- Clinically active liver disease, including liver cirrhosis that is Child-Pugh class B or C
- Second primary malignancy that has not been in remission for at least 3 years.
Sites / Locations
- USC Norris Comprehensive Cancer Center
- University of California San Francisco
- University of Colorado Hospital
- Northwestern University
- University of Chicago
- Massachusetts General Hospital
- Karmanos Cancer Institute
- New York Presbyterian Hospital-Columbia University Medical Center.
- Oregon Health & Science University Knight Cancer Institute
- Fox Chase Cancer Center
- Sarah Cannon Research Institute
- Mary Crowley Cancer Research
- UT Southwestern Medical Center
- University of Wisconsin Carbone Cancer Center
- The Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1 (Dose Escalation)
Part 2 (Dose Expansion)
HPN424 will be administered once weekly via IV infusion or subcutaneously with dose escalation until an estimated therapeutic dose level has been reached.
Patients will receive HPN424 at the recommended phase 2 dose(s) established in Part 1 of the study. Study procedures will be the same in Part 1 and Part 2 of the study. Additional expansion cohorts of up to 18 patients per expansion cohort may be added.