MC# 19-32 - A Phase I 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

  • Agent(s): HPN424
  • Disease Type(s): Prostate
  • Phase(s): I
  • Drug Classification(s): Bispecific Antibodies
  • Molecular Target(s): PSMA

Mechanism of Action

HPN424 TriTAC binds with high affinity and specificity to PSMA, CD3, and albumin which activates and redirects T cells to kill PSMA expressing cells.

Purpose

  • Assess initial safety of HPN424 and determine the recommended phase II dose
  • Evaluate activity of HPN424 at the recommended phase II dose
Inclusion Criteria
  • Male patients ≥18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • 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
  • 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
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 screening
  • 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
  • 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 or chronic liver disease
  • Second primary malignancy that has not been in remission for greater than 3 years

Location

More Info: https://clinicaltrials.gov/show/NCT03577028

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Re: MC# 19-32