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Study of HPN424 in Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03577028
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Harpoon Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Prostate Cancer Biological: HPN424 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicities [ Time Frame: Up to study day 21 ]
    In Part 1, measure incidence of dose limiting toxicities measured by adverse events and serious adverse events by dose level.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577028


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

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: University of California San Francisco       HDFCCC.CIP@ucsf.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Carol Gurski    617-643-1770    CGURSKI@mgh.harvard.edu   
United States, New York
New York Presbyterian Hospital-Columbia University Medical Center. Recruiting
New York, New York, United States, 10032
Contact: Bridget James    212-304-5543      
United States, Oregon
Oregon Health & Science University Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Shaadi Tabatabaei    503-494-6179    tabataba@ohsu.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Fox Chase Cancer Center    215-214-1515      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute         
Contact    1-844-482-4812      
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Mary Crowley Cancer Research    972-566-3000    Referral@MaryCrowley.org   
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Kevin Courtney, MD    214-648-4180    Kevin.Courtney@utsouthwestern.edu   
United Kingdom
The Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Mahesha Ganegoda    +44 (0)20 8642 6011 ext 1448    Mahesha.Ganegoda@icr.ac.uk   
Sponsors and Collaborators
Harpoon Therapeutics
More Information
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Responsible Party: Harpoon Therapeutics
ClinicalTrials.gov Identifier: NCT03577028    
Other Study ID Numbers: HPN424-1001
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases