The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
FG-3246 will be administered per schedule specified in the arm description.
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
Time frame: Until radiographic progression is noted (up to approximately 25 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose until 28 days after last dose (up to approximately 25 months)
Maximum Plasma Concentration (Cmax) of FG-3246, Total Anti-cluster of Differentiation 46 Antibody (CD46), and Free Monomethyl Auristatin E (MMAE)
Time frame: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
rPFS Rate at 6 Months (rPFS6) Per RECIST v1.1 and PCWG3 Criteria
Time frame: Month 6
rPFS Rate at 12 Months (rPFS12) Per RECIST v1.1 and PCWG3 Criteria
Time frame: Month 12
Confirmed Objective Response Rate (ORR) Per RECIST v1.1 and PCWG3 Criteria
Time frame: From first dose up to approximately 25 months
Duration of Response (DoR) Per RECIST v1.1 and PCWG3 Criteria
Time frame: From first dose up to approximately 25 months
Confirmed PSA50 Response Rate: Percentage of Participants Achieving a Decline in Prostate-specific Antigen (PSA) ≥50% From Baseline
Time frame: Up to approximately 25 months
Confirmed PSA90 Response Rate: Percentage of Participants Achieving a Decline in PSA ≥90% From Baseline
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Goodyear, Arizona, United States
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Scottsdale, Arizona, United States
RECRUITINGThe University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
RECRUITINGVA Greater Los Angeles Healthcare System
Los Angeles, California, United States
RECRUITINGUCLA Clark Urology Center
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RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGNew Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGBioresearch Partner - Aventura
Aventura, Florida, United States
RECRUITINGBioresearch Partner - Hialeah
Hialeah, Florida, United States
RECRUITINGBiogenix Molecular, LLC
Miami, Florida, United States
RECRUITING...and 13 more locations
Time frame: Up to approximately 25 months
Composite Response Rate (CRR) Per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
PSA Progression-free Survival (PFS)
Time frame: Up to approximately 25 months
Disease Control Rate (DCR) per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
Clinical Benefit Rate (CBR) per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
Time to First Symptomatic Skeletal-related Event (SSRE)
Time frame: Up to approximately 25 months
Overall Survival (OS)
Time frame: Until death or up to approximately 25 months
Percentage of Participants Who Develop Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against FG-3246
Time frame: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)