Study Summary
This trial is investigating a new drug, FOR46, that targets CD46 in prostate cancer. CD46 is a protein that is found on the surface of many types of cells, and is particularly common in adenocarcinoma and Small-cell neuroendocrine carcinoma (SCNC), which are two aggressive and deadly forms of prostate cancer. The goal of the trial is to see if FOR46 can be used to treat these aggressive forms of prostate cancer, and to help develop new treatments that improve outcomes for men with these types of cancer.
Eligible Conditions
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 7 Secondary · Reporting Duration: Up to 24 months
Up to 24 months
Average SUVmax (SUVmax-ave)
Average organ uptake of 89Zr-DFO-YS5
Inter-participant heterogeneity (Cohort C)
Inter-tumoral heterogeneity (Cohort C)
Intra-tumoral uptake of 89Zr-DFO-YS5 by Site of Disease (Cohort C)
Intra-tumoral uptake of 89Zr-DFO-YS5 by tumor type (Cohort C)
Median SUVmax
Proportion of participants with metastatic lesions accurately detected in mCRPC using 89Zr-DFO-YS5 PET (sensitivity) (Cohort C)
Tumor-to-background signal (Cohort C)
Week 3
Proportion of participants with treatment-related Adverse Events
Up to 7 days
Optimal antibody dose for imaging using 89Zr-DFO-YS5 PET (Cohort B)
Optimal time point for imaging using 89Zr-DFO-YS5 PET post-injection (Cohort A)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Cohort A: 89Zr-DFO-YS5
1 of 3
Cohort C: YS5, 89Zr-DFO-YS5 with scan at progression
1 of 3
Cohort B: YS5, 89Zr-DFO-YS5, Multiple Scans
1 of 3
Experimental Treatment
24 Total Participants · 3 Treatment Groups
Primary Treatment: 89Zr-DFO-YS5 · No Placebo Group · Phase 1
Cohort A: 89Zr-DFO-YS5Experimental Group · 3 Interventions: 89Zr-DFO-YS5, Positron Emission Tomography (PET)/Computerized tomography (CT), Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) · Intervention Types: Drug, Procedure, Procedure
Cohort C: YS5, 89Zr-DFO-YS5 with scan at progressionExperimental Group · 4 Interventions: 89Zr-DFO-YS5, YS5 antibody, Positron Emission Tomography (PET)/Computerized tomography (CT), Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) · Intervention Types: Drug, Biological, Procedure, Procedure
Cohort B: YS5, 89Zr-DFO-YS5, Multiple ScansExperimental Group · 4 Interventions: 89Zr-DFO-YS5, YS5 antibody, Positron Emission Tomography (PET)/Computerized tomography (CT), Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) · Intervention Types: Drug, Biological, Procedure, Procedure
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
Robert Flavell, MD, PhDLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
United States Department of DefenseFED
779 Previous Clinical Trials
202,395 Total Patients Enrolled
34 Trials studying Prostate Cancer
5,028 Patients Enrolled for Prostate Cancer
Fortis Therapeutics, Inc.Industry Sponsor
3 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Prostate Cancer
36 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
You are eligible for this trial if you have a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Total bilirubin <1.5 x ULN.
Creatinine clearance > 60 mL/min.
You are able to understand a written informed consent document, and you are willing to sign it.
You are currently progressing by PCWG3 criteria at the time of study entry.
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Conditions
Cancer Related
Treatments