PT-112 in mCRPC (Prostate Cancer)

What is the Purpose of this Study?

If you choose to join this study, you will:
- Receive the study drug through a vein in your arm (IV) once every 2 weeks
- Have blood draws
- Have imaging tests (CT, MRI, and/or bone scan)
What is the Condition Being Studied?
Metastatic, Castrate-Resistant Prostate Cancer (mCRPC)

Who Can Participate in this Study?

Adults who:

- Are diagnosed with mCRPC

- Are currently taking an androgen deprivation therapy OR have had a bilateral orchiectomy

- Have previously received at least 3 prior therapies for mCRPC, including at least one next-generation anti-androgen therapy and at least one taxane-containing therapy

For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to learn if a new study drug called PT-112 is a safe and effective treatment for metastatic, castrate-resistant prostate cancer. This study is one of the first times PT-112 is being tested in humans. The study drug has been shown to induce cell death in tumor cells, and shrink tumors in animal studies. This study will also teach us how long the study drug stays in your body after you receive it.

Study Details

Full Title
A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts: Cohort D A Phase 1/2, Open-Label Expansion Cohort to Evaluate the Safety and Preliminary Evidence of Efficacy of 360 mg/m2 or 250 mg/m2 PT-112 Given Bi-weekly in Late-line Treatment of Patients with mCRPC
Principal Investigator

Contacts
Protocol Number
IRB:
PRO00110069

NCT:
NCT04729114
ClinicalTrials.gov
View on ClinicalTrials.gov