OncoMatch/Clinical Trials/NCT06842498
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Is NCT06842498 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies FG-3246 for metastatic castration-resistant prostate cancer.
Treatment: FG-3246 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Excluded: CD46 therapeutic targeting
Participant has received previous treatment with a therapeutic targeting CD46
Excluded: BRCA1 mutation
Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: second-generation antiandrogen (abiraterone acetate, enzalutamide, apalutamide, darolutamide) — castration-sensitive or castration-resistant
progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting
Cannot have received: second-generation antiandrogen (abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Exception: progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting
Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting
Cannot have received: chemotherapy
Exception: one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed >12 months before randomization
Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed >12 months before randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Bioresearch Partner - Aventura · Aventura, Florida
- Bioresearch Partner - Hialeah · Hialeah, Florida
- Winship Cancer Institute, Emory University · Atlanta, Georgia
- East Jefferson General Hospital Metairie · New Orleans, Louisiana
- New Mexico Oncology Hematology Consultants, Ltd. · Albuquerque, New Mexico
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06842498 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior second-generation antiandrogen, chemotherapy disqualifies patients from enrollment.
Are patients with CD46 alterations eligible?
No. CD46 therapeutic targeting is an exclusion criterion.
Are patients with BRCA1 alterations eligible?
No. BRCA1 mutation is an exclusion criterion.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages