Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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):
  4. 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
  5. Radiographic evidence of metastatic disease
  6. Disease progression on the prior systemic regimen
  7. Must have received at least 2 prior systemic therapies approved for mCRPC
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  9. Adequate bone marrow function
  10. Able to read, understand and provide written informed consent

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental: HPN424-1001
In Part 1 (Dose Escalation), HPN424 will be administered once weekly via IV infusion with dose escalation until an estimated therapeutic dose level has been reached. In Part 2 (Dose Expansion), 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.
  • Biological: HPN424
    In Part 1 (Dose Escalation), HPN424 will be administered once weekly via IV infusion. In Part 2 (Dose Expansion), HPN424 will be administered at the recommended phase 2 dose(s) once weekly via IV infusion.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Carol Gurski
617-643-1770
CGURSKI@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Harpoon Therapeutics

Study Contact

Harpoon Therapeutics
1-650-689-1047
HPN4241001@harpoontx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.