Study of HPN424 in Patients With Advanced Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT03577028 |
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Recruitment Status :
Recruiting
First Posted : July 5, 2018
Last Update Posted : October 5, 2020
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Sponsor:
Harpoon Therapeutics
Information provided by (Responsible Party):
Harpoon Therapeutics
- Study Details
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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 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 Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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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. |
Primary Outcome Measures :
- 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.
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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:
- Male patients ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
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Progressive metastatic castrate-resistant prostate cancer (mCRPC):
- 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
- Radiographic evidence of metastatic disease
- 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
Key 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 first dose of study drug
- 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 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
- 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 liver disease, including liver cirrhosis that is Child-Pugh class B or C
- Second primary malignancy that has not been in remission for at least 3 years.
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
| Contact: Harpoon Therapeutics | 1-650-689-1047 | HPN4241001@harpoontx.com |
Locations
| 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
| 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 |
| 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 |