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Protocol # 19-618

Status

Active, not recruiting

Description

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

  • Advanced Prostate Cancer

Interventions

  • HPN424 In Part 1 (Dose Escalation)
  • HPN424 In Part 2 (Dose Expansion)

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Part 1: Number and severity of dose limiting toxicities (DLTs) of HPN424
  • Part 2: Overall response rate (ORR) as assessed by PCWG3 criteria for response

Secondary Outcome:

  • Part 1 and 2: Adverse events (NCI CTCAE version 5.0)
  • Part 1: Progression-free survival (PFS) using PCWG3 criteria
  • Part 1: Duration of response (DOR) using PCWG3 criteria
  • Part 1: Overall survival (OS)
  • Part 1: Prostate Specific Antigen (PSA) levels
  • Part 1 and 2: Pharmacokinetics of HPN424
  • Part 1 and 2: Incidence of anti-drug antibodies (ADA) against HPN424
  • Part 1 and 2: Effects of HPN424 on circulating lymphocytes and systemic soluble immune factors

Enrollment

110

Study Start Date

July 24, 2018

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Harpoon Therapeutics

Source

Harpoon Therapeutics

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

Clinicaltrials.gov Identifier

NCT03577028

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.