Study of HPN424 in Patients With Advanced Prostate Cancer

  • Interventional
  • Recruiting
  • NCT03577028
Eligibility Details Visit Clinicaltrials.gov

A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients With Advanced Prostate Cancer Refractory to Androgen Therapy

An open-label, Phase 1/2a, study of HPN424 as monotherapy to assess the safety, tolerability and PK in patients with advanced prostate cancer refractory to androgen therapy

Gender
Male

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         1. Male patients ≥18 years of age

         2. Histologically or cytologically confirmed adenocarcinoma of the prostate

         3. Progressive metastatic castrate-resistant prostate cancer (mCRPC):

             1. 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

             2. Radiographic evidence of metastatic disease

             3. Disease progression on the prior systemic regimen

         4. Must have received at least 2 prior systemic therapies approved for mCRPC

         5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

         6. Adequate bone marrow function

         7. Able to read, understand and provide written informed consent

        Key Exclusion Criteria:

         1. Previously treated or current brain metastases

         2. Untreated spinal cord compression. Participants must be neurologically stable off steroids for at least 4 weeks prior to first dose of study drug

         3. 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

         4. 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)

         5. 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

         6. 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

         7. Clinically active liver disease, including liver cirrhosis that is Child-Pugh class B or C

         8. Second primary malignancy that has not been in remission for at least 3 years.

At a Glance

National Government IDNCT03577028

IRB#IRB20-0304

Lead SponsorHarpoon Therapeutics

Lead PhysicianRussell Z. Szmulewitz

Collaborator(s)N/A

EligibilityMale
18 Years and up
Recruiting