RecruitingPhase 1Phase 2NCT07259213

A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-Kallikrein-Related Peptidase 3 (KLK3) Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants With Castration-Resistant Prostate Cancer (CRPC)


Sponsor

Radiopharm Theranostics, Ltd

Enrollment

73 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-KLK3 Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants with Castration-Resistant Prostate Cancer (CRPC).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug called 161Tb-RAD402 in men with castration-resistant prostate cancer (CRPC) — a form of prostate cancer that has stopped responding to hormone-lowering therapy. **You may be eligible if...** - You are a male aged 18 or older - You have confirmed advanced or metastatic prostate cancer that has progressed despite hormone therapy (castrate testosterone levels) - Your PSA (a prostate cancer marker) is rising, or your cancer has spread or grown on imaging - You have received prior standard treatments including certain hormone-blocking drugs **You may NOT be eligible if...** - You have poor kidney, liver, or bone marrow function - You have had certain prior radioactive treatments - You have significant other medical conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG161Tb RAD402

161Tb RAD402 administered at treatment doses


Locations(2)

Wollongong Hospital

Wollongong, New South Wales, Australia

Icon Cancer Centre Hollywood

Nedlands, Western Australia, Australia

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NCT07259213


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