NCT07259213

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Radiopharm Theranostics, Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to establish the safety profile, biodistribution, pharmacokinetics (PK), and radiation dosimetry of 161Tb-RAD402, to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate preliminary anti-tumor activity in participants with locally advanced or metastatic Castration-Resistant Prostate Cancer (CRPC). The study is divided into 2 phases. Phase 1 is the dose escalation phase to establish the safety profile of 161Tb-RAD402 and to determine the MTD and/or RP2D of 161Tb-RAD402 using a Bayesian Optimal Interval (BOIN) design. Phase 2a is the dose expansion phase at the RP2D to confirm the safety of the MTD and/or RP2D and to evaluate preliminary anti-tumor activity of 161Tb-RAD402 using a probability of success design for Prostate Specific Antigen (PSA)50 based on a Bayesian beta-binomial design. Participants ≥ 18 years of age with CRPC who have documented disease progression during or after their most recent line of anticancer therapy will be eligible to enroll. Each phase consists of a Screening Period, a Treatment and Imaging Period, and a Safety and Long-term Follow-up Period.

Conditions

• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	161Tb RAD402	161Tb RAD402 administered at treatment doses

Timeline

• Start date: 2026-03-05
• Primary completion: 2028-11-30
• Completion: 2029-03-30
• First posted: 2025-12-02
• Last updated: 2026-04-01

Locations

2 sites across 1 country: Australia