A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
Kyntra Bio
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: * Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma. * Participant with safely accessible tumor lesion must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide an archival biopsy of a primary or metastatic lesion that was taken after castration resistance developed and within 1 year prior to randomization. * Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening. * Participant is required to have progressed on one prior treatm…
Interventions
- DrugFG-3246
FG-3246 will be administered per schedule specified in the arm description.
Locations (15)
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- UCLA Clark Urology CenterLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Bioresearch PartnerAventura, Florida
- Bioresearch PartnerHialeah, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia