A Study of FG-3246 for Prostate Cancer
Phase 2
75
about 2.2 years
18+
Male only
15 sites in AZ, CA, FL +8
What this study is about
This trial is testing a new drug called FG-3246 in men with prostate cancer that has spread and hasn't responded to other treatments. The goal is to see if this treatment is safe, effective, and how it works in the body.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take FG-3246
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Maximum Plasma Concentration (Cmax) of FG-3246, Total Anticluster of Differentiation 46 Antibody (CD46), and Free Monomethyl Auristatin E (MMAE), Number of Participants With Treatment-emergent Adverse Events (TEAEs), Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria
Secondary: Composite Response Rate (CRR) Per RECIST 1.1 and PCWG3 Criteria, Confirmed Objective Response Rate (ORR) Per RECIST v1.1 and PCWG3 Criteria, Confirmed PSA50 Response Rate: Percentage of Participants Achieving a Decline in Prostate-specific Antigen (PSA) ≥50% From Baseline, Confirmed PSA90 Response Rate: Percentage of Participants Achieving a Decline in PSA ≥90% From Baseline, Disease Control Rate (DCR) per RECIST 1.1 and PCWG3 Criteria, Duration of Response (DoR) Per RECIST v1.1 and PCWG3 Criteria, Overall Survival (OS), PSA Progression-free Survival (PFS)
Oncology