FibroGen: FG-3246 for mCRPC (Metastatic Castration-Resistant Prostate Cancer)

FibroGen: FG-3246 for mCRPC (Metastatic Castration-Resistant Prostate Cancer)

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Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called FG-3246 (the study drug) that is being developed for people with metastatic castration-resistant prostate cancer. We want to know if it is able to shrink the size of tumors and delay the progression of the disease.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with prostate adenocarcinoma
  • Have serum testosterone levels <50 ng/dL
  • Have had their disease progress on one previous treatment with a second-generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide)
  • Have never had previous treatment with a therapeutic targeting CD46
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

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 different groups. Depending on your assignment, you will either:
  • Get a lower dose of the study drug; OR
  • Get a medium dose of the study drug; OR
  • Get a higher dose of the study drug
The study drug is given as an intravenous (IV) infusion into a vein in your arm. You will get your assigned dose of the study drug once every 21 days. The number of doses of the study drug that you get will depend on how your body responds to the drug (i.e., until the study doctor decides that you are no longer receiving a positive benefit or it is no longer necessary to take the drug).

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients with Metastatic Castration-Resistant Prostate Cancer, FGCL-3246-112

Principal Investigator

Andrew
Armstrong

Protocol Number

PRO00117810

NCT ID

NCT06842498

Phase

II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov