IRB #

STUDY00020325

Title

[IntegReview IRB - IAA] 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

Principal Investigator

Tomasz Beer

Study Purpose

The purpose of this study is to test the good and/or bad effects, mechanism of action, and efficacy of an experimental drug called HPN424 in participants with advanced prostate cancer. Additionally, the study will analyze how the body metabolizes the study drug over time.

Medical Condition(s)

Metastatic castration resistant prostate cancer(mCRPC)

Eligibility Criteria

-Subjects should have metastatic castration-resistant prostate cancer.
-Subjects should have at least two prior systemic treatment approved for the castration-resistant setting
-Subjects may previously be treated with a second-generation hormone therapy (eg, enzalutamide or equivalent or with abiraterone acetate).
-Subjects should not have concurrent or recent treatment with drugs that help stop inflammation, systemic steroids, or other immune suppressive drugs.
-Subjects should not have any history of or current brain metastases.

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the investigational drug for up to 3 years. There will be one follow up visit 28 days after the last dose of the study drug. After discontinuation of the study drug, participants will be contacted by phone monthly for 6 months and every 3 months thereafter.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Harpoon Therapeutics, Inc.

Recruitment End

12/31/2022

Compensation Provided

No


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