NCT06824155

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Radiopharm Theranostics, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a first-in-human, Phase 0/1, open-label study of 177Lu-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. Screening Period: Screening period of up to 4 weeks Phase 0 (Imaging Period): Low dose (10mCi) 177Lu-RAD202 administered on Imaging Day 1 with a follow-up period of up to 2 weeks to assess imaging, safety and dosimetry. Following assessment of the imaging, safety and dosimetry results of the first 3 to 6 participants dosed with 10mCi 177Lu-RAD202im the dose may be increased in subsequent participants, if needed, to improve image quality. Phase I (Treatment Period): 177Lu-RAD202tr dose escalation * Treatment Period with each cycle lasting 6 weeks. Extension of the planned dose intervals are possible following discussion and agreement between the Sponsor and Investigator. * Participants may be treated with multiple cycles as long as they appear to derive clinical benefit as determined by the Investigator and provided adequate clinical safety and organ dosimetry data. * DLT observation period for 177Lu-RAD202tr is 6 weeks following first injection of 177Lu-RAD202tr. * Should an alternative treatment schedule be explored, the DLT observation period for 177Lu-RAD202tr at that dose level will be the proposed cycle duration.

Conditions

• HER2 Gene Mutation
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	177Lu-RAD202	177Lu-RAD202 administered at Imaging (im) and Treatment (tr) doses

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-02-13
• Last updated: 2026-02-11

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study