Clinical Trials /

Study of HPN424 in Patients With Advanced Prostate Cancer

NCT03577028

Description:

An open-label, Phase 1, study of HPN424 as monotherapy to assess the safety, tolerability and PK in patients with advanced prostate cancer refractory to androgen therapy

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of HPN424 in Patients With Advanced Prostate Cancer
  • Official Title: A Phase 1 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

Clinical Trial IDs

  • ORG STUDY ID: HPN424-1001
  • NCT ID: NCT03577028

Conditions

  • Advanced Prostate Cancer

Interventions

DrugSynonymsArms
HPN424Experimental: HPN424-1001

Purpose

An open-label, Phase 1, study of HPN424 as monotherapy to assess the safety, tolerability and PK in patients with advanced prostate cancer refractory to androgen therapy

Trial Arms

NameTypeDescriptionInterventions
Experimental: HPN424-1001ExperimentalIn 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.
  • HPN424

Eligibility 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): a) 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, b) radiographic evidence of metastatic disease and c)
             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 Screening

          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

          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 or chronic liver disease,

          8. Second primary malignancy that has not been in remission for greater than 3 years.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicities
Time Frame:Up to study day 21
Safety Issue:
Description:In Part 1, measure incidence of dose limiting toxicities measured by adverse events and serious adverse events by dose level.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Harpoon Therapeutics

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