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Study of HPN424 in Patients With Advanced Prostate Cancer

NCT03577028 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-02-14

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2023-02-27
Completion
2023-02-27
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577028 on ClinicalTrials.gov