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Radiopharmaceutical

Phase I/II 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Scott Tagawa, MD MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be collected at the time of visit 1 through end of study or 100 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial tests two special drugs that deliver radiation directly to prostate cancer cells. It targets men with advanced prostate cancer that doesn't respond to hormone therapy. The drugs work by finding and attaching to cancer cells, then releasing radiation to destroy them. A drug that delivers radioactive isotopes to specific cancer cells has been shown to prolong the lives of men with advanced prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be collected at the time of visit 1 through end of study or 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be collected at the time of visit 1 through end of study or 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
Change in biochemical progression-free survival
Body Weight Changes
Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment3 Interventions
Patients enrolled in the study will receive the study drugs 225Ac-J591 and 177Lu-PSMA-I\&T, along with 68Ga-PSMA-11.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
225Ac-J591
2017
Completed Phase 1
~40
Gallium Ga-68 gozetotide
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,738 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,610 Patients Enrolled for Prostate Cancer
POINT BiopharmaIndustry Sponsor
5 Previous Clinical Trials
674 Total Patients Enrolled
1 Trials studying Prostate Cancer
142 Patients Enrolled for Prostate Cancer
Scott Tagawa, MD MSPrincipal InvestigatorWeill Medical College of Cornell University
Joseph Osborne, MDPrincipal InvestigatorWeill Medical College of Cornell University
~11 spots leftby Dec 2025
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