RAD202

DEVELOPMENT STEP phase-1

SPONSOR MATRIX Radiopharm Theranostics [RADX]

MECHANISM TARGET HER2

[THERAPEUTIC_PROFILE]

Target Indications

HER2 Positive Solid Tumors

Mechanism Abstract

A nanobody bearing Lu177 isotope

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED1

RECRUITING STATUS1

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

E-P-1NCT06824155

HER2 Gene MutationAdvanced Solid Tumors

N=30Est. Finish: 2027-12

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

recruiting

ENROLLMENT PATIENT CAPACITY30 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2025-02-12(actual)

Primary End:2027-12(estimated)

Study Finish:2027-12(estimated)

OFFICIAL PROTOCOL TITLE

Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD202, a Lutetium-177 Radiolabeled Single Domain Antibody Against Human Epidermal Growth Factor Receptor 2 in Patients With Advanced Solid Tumours

[INVESTIGATORS_&_FACILITY_ROSTER]

Veronica Wong, MDCONTACT — Nepean Hospital

Dhanusha Sabanathan, MDCONTACT — Macquarie University Hospital

Udit Nindra, MDCONTACT — Wollongong Hospital

Melissa Moore, MDCONTACT — St Vincents Hospital, Melbourne

Aviral Singh, MDCONTACT — GenesisCare Murdoch

Dimitris Voliotis, MDCONTACT — Radiopharm Theranostics, Ltd

[PRIMARY_SUCCESS_ENDPOINTS]

Time Activity Curves (TACs)

Analysis Window: 72 hours

Radiation dosimetry of Lu177-RAD202im

Analysis Window: 72 hours

Safety and tolerability of a single dose of 177Lu-RAD202tr

Analysis Window: 6 weeks

Recommended dose(s) of 177Lu-RAD202tr for future exploration

Analysis Window: 6 weeks

[SECONDARY_SUCCESS_ENDPOINTS]

Safety and tolerability of 177Lu-RAD202im

Analysis Window: 6 weeks

Recommended dose(s) of 177Lu-RAD202im for future exploration

Analysis Window: 2 weeks

Preliminary antitumor activity of 177Lu-RAD202tr

Analysis Window: Up to 30 weeks

Radiation dosimetry of 177Lu-RAD202tr

Analysis Window: 72 hours

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

177Lu-RAD202

EXPERIMENTAL

Single-arm, open-label study of 177Lu-RAD202 consisting of a Phase 0 Imaging Period (Im) and a Phase 1 Treatment Period (Tr)

[DOSING_&_INTERVENTION_SPECIFICITIES]

177Lu-RAD202DRUG

177Lu-RAD202 administered at Imaging (im) and Treatment (tr) doses