Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called pocenbrodib (the study drug). We want to see how it works when it is given by itself and also when it is given with other drugs already approved for the treatment in people with metastatic castration-resistant prostate cancer (mCRPC).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with prostate adenocarcinoma
- Have metastases that are documented by imaging
- Had their disease progress after or during previous ARSI treatment (i.e., enzalutamide, apalutamide, abiraterone acetate, or darolutamide)
- Do not have metastases to the liver
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study is designed in 2 parts, Phase 1b and Phase 2a. The Phase 1b part starts first and the Phase 2a part will start when Phase 1b ends. You will take part in either Phase 1b or Phase 2a. If you choose to join this study, the part in which you participate will depend on when you join.
Phase 1b will test the safety of study drug when it is given by itself at up to 5 different dose levels. The dose levels to be tested are:
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 250 mg
- Cohort B - pocenbrodib + abiraterone acetate (by mouth daily)
- Cohort C - pocenbrodib + olaparib (by mouth daily)
- Cohort D - pocenbrodib + 177Lu-PSMA-617 (PLUVICTO®; given by vein via a needle in your arm once every six weeks up to 6 treatments)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1b/2a, Multicenter, Open-Label Study of Pocenbrodib as Monotherapy and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), P300-02-001
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00116829
NCT ID
NCT06785636
Phase
I/II
Enrollment Status
Open to Enrollment