RAD101

DEVELOPMENT STEP phase-2

SPONSOR MATRIX Radiopharm Theranostics [RADX]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

Brain Metastases

Mechanism Abstract

A small molecule bearing a F18 isotope

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED1

RECRUITING STATUS0

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-2NCT06777433

Brain Metastases From Solid Tumors

N=30Est. Finish: 2026-10

Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases

active not recruiting

ENROLLMENT PATIENT CAPACITY30 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2024-12-13(actual)

Primary End:2026-04-23(actual)

Study Finish:2026-10(estimated)

OFFICIAL PROTOCOL TITLE

An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants With Suspected Recurrent Brain Metastases From Solid Tumors

[INVESTIGATORS_&_FACILITY_ROSTER]

Dimitris Voliotis, MDSTUDY DIRECTOR — Radiopharm Theranostics

[PRIMARY_SUCCESS_ENDPOINTS]

Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

Analysis Window: 1 Week

Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

Analysis Window: 1 Week

Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

Analysis Window: 1 Week

[SECONDARY_SUCCESS_ENDPOINTS]

Accuracy of RAD101 in identifying tumor recurrence versus radiation necrosis in previously SRS-treated brain metastasis

Analysis Window: 6 months

Safety and tolerability of a single dose of RAD101

Analysis Window: 48 Hours

Optimal dose of RAD101

Analysis Window: 1 week

Performance of RAD101 PET in identifying tumor lesions

Analysis Window: 1 week

Performance of RAD101 PET in identifying tumor lesions

Analysis Window: 1 week

Performance of RAD101 PET in identifying tumor lesions

Analysis Window: 1 week

Performance of RAD101 PET in identifying tumor lesions

Analysis Window: 1 week

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

RAD101 (18F-Fluorescence polarization immunoassay (FPIA))

EXPERIMENTAL

370 MBq (10 mCi) single dose administered at Day 1 visit

[DOSING_&_INTERVENTION_SPECIFICITIES]

RAD101 (18F-FPIA)DRUG

A single dose of 18F-RAD101 with a maximum of 370 MBq (10 mCi) administered as a slow IV bolus injection over a maximum of 30 seconds, followed by a saline flush.