Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Lawrence Fong

Description

Summary

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

Official Title

A Phase 1 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

Keywords

Advanced Prostate Cancer Prostatic Neoplasms HPN424

Eligibility

For males ages 18 years and up

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): a) 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, b) radiographic evidence of metastatic disease and c) 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 Screening
  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
  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 or chronic liver disease,
  8. Second primary malignancy that has not been in remission for greater than 3 years.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Oregon Health & Science University Knight Cancer Institute accepting new patients
    Portland Oregon 97239 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Harpoon Therapeutics
ID
NCT03577028
Phase
Phase 1
Study Type
Interventional
Last Updated