Clincosm LogoSign in Get a demo

Study of HPN424 in Patients With Advanced Prostate Cancer

Sponsor
Harpoon Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03577028
Collaborator
(none)
40
Enrollment
9
Locations
1
Arm
28.1
Anticipated Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: HPN424
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 31, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of dose limiting toxicities [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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):

  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

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

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94143
2 Massachusetts General Hospital Boston Massachusetts United States 02114
3 New York Presbyterian Hospital-Columbia University Medical Center. New York New York United States 10032
4 Oregon Health & Science University Knight Cancer Institute Portland Oregon United States 97239
5 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
6 Sarah Cannon Research Institute Nashville Tennessee United States 37203
7 Mary Crowley Cancer Research Dallas Texas United States 75230
8 UT Southwestern Medical Center Dallas Texas United States 75390
9 The Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT

Sponsors and Collaborators

  • Harpoon Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harpoon Therapeutics
ClinicalTrials.gov Identifier:
NCT03577028
Other Study ID Numbers:
  • HPN424-1001
First Posted:
Jul 5, 2018
Last Update Posted:
Oct 5, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Oct 5, 2020