Alpi-Sat: Ac-225-Labeled Antibody for Prostate Cancer

Alpi-Sat: Ac-225-Labeled Antibody for Prostate Cancer

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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
For more information, contact the study team at julia.hurrelbrink@duke.edu.

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.
If you choose to join this study, the part of the study in which you participate will depend on when you join. The study team can let you know which part is open to participants before you make your decision. Both study drugs are given as intravenous (IV) infusions. The number of doses you get will depend on how you respond to the study drug(s).

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