225Ac-J591 for Prostate Cancer

Phase-Based Progress Estimates
Prostate Cancer225Ac-J591 - Drug
18 - 99
What conditions do you have?

Study Summary

This trial is testing a new combination of two drugs, 225Ac-J591 and 177Lu-PSMA-I&T, to see if it is safe and effective in treating prostate cancer.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Will be collected at the time of visit 1 through end of study or 100 months

Week 24
Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment
Number of subjects with radiographic response rate
Week 24
Body Weight Changes
Month 100
Overall survival following treatment with 225Ac-J591 and 177Lu-PSMA-I&T
Month 100
Change in biochemical progression-free survival
Cumulative maximum tolerated dose (MTD) and recommended phase II dose 225Ac-J591 and 177Lu-PSMA I&T
Proportion of PSMA+ subjects (by imaging criteria) with PSA decline following treatment with the combination of 225Ac-J591 and 177Lu-PSMA I&T.
Proportion of subjects with dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA-I&T during dose-escalation phase.
Month 100
Safety of treatment and adverse event rate

Trial Safety

Trial Design

1 Treatment Group

All Subjects
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: 225Ac-J591 · No Placebo Group · Phase 1 & 2

All SubjectsExperimental Group · 3 Interventions: 225Ac-J591, 177Lu-PSMA-I&T, 68Ga-PSMA-11 · Intervention Types: Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga-68 gozetotide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: will be collected at the time of visit 1 through end of study or 100 months

Who is running the clinical trial?

POINT BiopharmaIndustry Sponsor
3 Previous Clinical Trials
545 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
989 Previous Clinical Trials
1,338,897 Total Patients Enrolled
46 Trials studying Prostate Cancer
49,156 Patients Enrolled for Prostate Cancer
Scott Tagawa, MD MSPrincipal InvestigatorWeill Medical College of Cornell University

Eligibility Criteria

Age 18 - 99 · Male Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have normal organ and marrow function as defined below: Absolute neutrophil count: >2,000 cells/mm3, Hemoglobin: ≥9 g/dL, Platelet count: >150,000 x 109/uL, Serum creatinine: <1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin: <1.
You have adenocarcinoma of the prostate.
You have previously been treated with at least one of the following: Androgen receptor signaling inhibitor (such as enzalutamide), CYP 17 inhibitor (such as abiraterone acetate).
You have previously received taxane chemotherapy.
You are able to understand and sign a written informed consent document.