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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

Tracking Information
First Submitted Date  ICMJE June 22, 2018
First Posted Date  ICMJE July 5, 2018
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of HPN424 in Patients With Advanced Prostate Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Biological: HPN424
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Harpoon Therapeutics 1-650-689-1047 HPN4241001@harpoontx.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03577028
Other Study ID Numbers  ICMJE HPN424-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harpoon Therapeutics
Study Sponsor  ICMJE Harpoon Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Harpoon Therapeutics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP