RAD402

DEVELOPMENT STEP phase-1

SPONSOR MATRIX Radiopharm Theranostics [RADX]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

KLK3 Positive Prostate Cancer

Mechanism Abstract

A Monoclonal Antibody bearing Tb161 isotope

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED1

RECRUITING STATUS1

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-1NCT07259213

Castration-resistant Prostate Cancer

N=73Est. Finish: 2029-03-30

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

recruiting

ENROLLMENT PATIENT CAPACITY73 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2026-03-05(actual)

Primary End:2028-11-30(estimated)

Study Finish:2029-03-30(estimated)

OFFICIAL PROTOCOL TITLE

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)

[INVESTIGATORS_&_FACILITY_ROSTER]

Dimitris Voliotis, MDCONTACT — Radiopharm Theranostics, Ltd

[PRIMARY_SUCCESS_ENDPOINTS]

Incidence of treatment emergent adverse events of 161Tb RAD402 (phase 1) (Safety)

Analysis Window: 6 weeks

Recommended dose(s) of 161Tb RAD402 for future exploration (phase 1)

Analysis Window: 6 weeks

Preliminary anti-tumor activity, as defined by biochemical response, in participants who are treated with 161Tb RAD402 at the RP2D (phase 2a)

Analysis Window: Up to 30 weeks

[SECONDARY_SUCCESS_ENDPOINTS]

Preliminary anti-tumor activity of 161Tb RAD402 (phase 1)

Analysis Window: Up to 30 weeks

Preliminary anti-tumor activity of 161Tb RAD402 as defined by biochemical response (phase 1)

Analysis Window: Up to 30 weeks

Pharmacokinetics of 161Tb RAD402 (phase 1)

Analysis Window: 120 hours

Radiation dosimetry of 161Tb RAD402 (phase 1)

Analysis Window: 120 hours

Biodistribution of 161Tb RAD402 (phase 1)

Analysis Window: 120 hours

Preliminary anti-tumor activity of 161TbRAD402 at the RP2D in participants with Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) positive CRPC previously treated with ≥1 Androgen Receptor Signalling Inhibitor (ARSI) (phase 2a)

Analysis Window: Up to 30 weeks

Incidence of treatment emergent adverse events of 161Tb RAD402 at the RP2D (phase 2a) (safety and tolerability)

Analysis Window: 6 weeks

Pharmacokinetics of 161Tb RAD402 at the RP2D (phase 2a)

Analysis Window: 120 hours

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

161Tb RAD402

EXPERIMENTAL

Single-arm, open-label study of 161Tb RAD402 consisting of Phase 1 Dose Escalation and Phase 2 Dose Expansion study parts.

[DOSING_&_INTERVENTION_SPECIFICITIES]

161Tb RAD402DRUG

161Tb RAD402 administered at treatment doses