Purpose of this Study
We are doing this study to find out if a pair of experimental drugs called JNJ-69086420 and JNJ-78278343 (the study drugs) are a safe and effective option for adults with advanced prostate cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have metastatic castrate-resistant prostate cancer and have been treated with at least 1 AR-targeted therapy; OR have metastatic hormone sensitive prostate cancer with non-castrate levels of testosterone (>150 ng/dL)
- Have never been treated with radium Xofigo® (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy
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 will be conducted in 4 parts:
- Part 1: Participants who take part in this portion of the study will get different doses of JNJ-69086420. This part of the study will allow us to find the maximum dose of the study drug that is safe to take.
- Part 2: Participants who take part in this portion of the study will continue to get different doses of JNJ-69086420, but these dose levels will be based on the findings from Part 1.
- Part 3: Participants who take part in this portion of the study will get a combination of both JNJ-69086420 and JNJ-78278343 to find out if taking both study drugs at the same time is safe and beneficial.
- Part 4: Only participants who have hormone sensitive prostate cancer (HSPC) will be able to take part in this portion of the study. We will test the best dose of JNJ-69086420 from Parts 1 and 2 to find out if it has a safe, beneficial effect for people with HSPC after they get standard body radiation therapy.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer, 69086420PCR1001
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00118421
NCT ID
NCT04644770
Phase
I
Enrollment Status
Pending Open to Enrollment