NCT03577028

Study of HPN424 in Patients With Advanced Prostate Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HPN424 Fixed IV 1.3 to 150 ng/kg	Fixed dose IV cohorts at doses from 1.3 to 150 ng/kg
BIOLOGICAL	HPN424 Prime Step IV 36 ng/kg Target	Step-dosing IV cohort at a single Prime Dose followed by the Target Dose (12/36 ng/kg)
BIOLOGICAL	HPN424 1 Prime Step IV 225-300 ng/kg Target	Step-dosing IV cohorts who received a single Prime Dose followed by the Target Dose (100/300 ng/kg and 75/225 ng/kg)
BIOLOGICAL	HPN424 2 Prime Step IV 300 ng/kg Target	Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (50/150/300 ng/kg with prior chemotherapy and 50/150/300 ng/kg no prior chemotherapy)
BIOLOGICAL	HPN424 2 Prime Step IV 450 ng/kg Target	Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (100/300/450 ng/kg and 50/150/450 ng/kg)
BIOLOGICAL	HPN424 Fixed SC	Fixed subcutaneous dose 120 ng/kg

Timeline

• Start date: 2018-07-24
• Primary completion: 2023-02-27
• Completion: 2023-02-27
• First posted: 2018-07-05
• Last updated: 2024-02-14
• Results posted: 2024-02-14

Locations

15 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study