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FG-3246

Phase 2

Metastatic Castration-Resistant Prostate Cancer | Small molecule | Oncology |Kyntra Bio, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06842498A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)PHASE2 RECRUITING 75 — — Feb 22, 2026Mar 31, 2028May 22, 202620 United States
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Study Endpoints
Primary Endpoints
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
Until radiographic progression is noted (up to approximately 25 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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)
Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
Secondary Endpoints
rPFS Rate at 6 Months (rPFS6) Per RECIST v1.1 and PCWG3 Criteria
Month 6
rPFS Rate at 12 Months (rPFS12) Per RECIST v1.1 and PCWG3 Criteria
Month 12
Confirmed Objective Response Rate (ORR) Per RECIST v1.1 and PCWG3 Criteria
From first dose up to approximately 25 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FG-3246 1.8 mg/kgEXPERIMENTALParticipants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks \[Q3W\]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.
FG-3246 2.4 mg/kgEXPERIMENTALParticipants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.
FG-3246 2.7 mg/kgEXPERIMENTALParticipants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.
Interventions
NameTypeDescription
FG-3246DRUGFG-3246 will be administered per schedule specified in the arm description.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites20

Key Inclusion Criteria: * Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies. * Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion dur...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06842498primaryCompletionDate: changed
LOWMay 24, 2026NCT06842498studyFirstPostDate: changed