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HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

Study acronym: RAD202
StatusRecruiting
PhaseEarly Phase 1
Started2025-02-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 6 → 2 primary endpoints
See other at-risk trials from Radiopharm Theranostics, Ltd

Amendment history

2026-09-25
Primary endpoint(s) modified6 to 2 entries
WasBiokinetics of 177Lu-RAD202im, Pharmacokinetics of 177Lu-RAD202im, Radiation dosimetry of Lu177-RAD202im, Recommended dose(s) of 177Lu-RAD202tr for future exploration, Safety and tolerability of a single dose of 177Lu-RAD202tr, Time Activity Curves (TACs)
NowRecommended dose(s) of 177Lu-RAD202 for future exploration, Safety and tolerability of 177Lu-RAD202
2026-02-08
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2027-09→2027-12
Completion date2027-09→2027-12
Enrollment target35→30
Study sites2→5
Eligibility criteria+622 characters
[...] ith histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed/refractory, locall [...] on IHC and positive results on in situ hybridisation (ISH). HER2-low is defined as a score of 1+ on IHC analysis or a score of 2+ on IHC analysis with ISH negative. If the participant tumor's HER2 status is unknown, it may be determined in a pre-screening step whereby the participant is asked to provide written informed consent to have their tumor tissue und [...] Must have at least 1 measurable target lesion according to R [...] effective method of contraception during the s [...]
Study description-384 characters
[...] period of up to 4 weeks Phase 0 (Imaging Period): Low dose (10mCi) 177Lu-RAD202 (starting at 10mCi) administered on Imaging Day 1 with a follow-up period of up to 2 weeks to assess imaging, safety and dosimetry. Following [...] simetry results of the first 3 to 6 participants dosed with 10mCi 177Lu-RAD202im (10mCi) the dose may be increased in subsequent participants, if needed, to improve image quality. Prior to determining the recommended dose level of 177Lu-RAD202im for future exploration, there is a minimum of 2 weeks between administration of 177Lu-RAD202im in Phase 0 and 177Lu-RAD202tr in Pha [...] [...]
2025-04-29
Study Identification, Study Status, Contacts/Locations v3
Study sites1→2
Study titlerevised
HEAT Trial (HER2 Antibody Therapy withWith Lutetium-177)
2025-03-12
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2025-03-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02→confirmed 2025-02-12
Study sites0→1
2025-02-07
Original filing
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
Trial Details
NCT Number NCT06824155
Lead Sponsor Radiopharm Theranostics, Ltd
Conditions HER2 Gene Mutation, Advanced Solid Tumors
Enrollment 30 participants
Start Date 2025-02-12
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-24