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Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

NCT05983198 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-29

No results posted yet for this study

Summary

This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

Conditions

Interventions

DRUG

225Ac-PSMA-R2

PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide

RADIATION

68Ga-PSMA-R2

Kit for radiopharmaceutical preparation

RADIATION

68Ga-PSMA-11

Kit for radiopharmaceutical preparation

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2026-11-19
Completion
2029-11-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983198 on ClinicalTrials.gov