HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
NCT06824155 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-11
Summary
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 consisting of an Imaging Period with 177Lu-RAD202im(imaging dose) and a Treatment Period with 177Lu-RAD202tr(treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
Conditions
- HER2 Gene Mutation
- Advanced Solid Tumors
Interventions
- DRUG
-
177Lu-RAD202
177Lu-RAD202 administered at Imaging (im) and Treatment (tr) doses
Sponsors & Collaborators
-
Radiopharm Theranostics, Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-12
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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