Actively Recruiting
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
Led by Radiopharm Theranostics, Ltd · Updated on 2026-02-11
30
Participants Needed
5
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and older
- Provide written informed consent
- Have histologically or cytologically confirmed HER2 positive or HER2-low advanced solid tumors that are relapsed/refractory, locally advanced not amenable to curative therapy, or metastatic with documented progression
- Be refractory to or intolerant of standard of care therapy or have no standard therapy likely to benefit
- Have at least one measurable target lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy of 4 months or more as judged by Investigator
- Women of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Women of childbearing potential must agree to use highly effective contraception during study and 90 days after last dose
- Male participants able to father children must agree to use highly effective contraception during study and 90 days after last dose and not donate sperm during specified periods
- Participants with previously treated brain metastases are eligible if neurologically and radiologically stable, not requiring steroids, and no history of leptomeningeal disease or spinal cord compression
- For Phase 1: Participants must have positive lesion(s) by 177Lu-RAD202im SPECT/CT per central review
You will not qualify if you...
- Have any other known active malignancy except treated cervical intraepithelial neoplasia or nonmelanoma skin cancer
- Have medical conditions preventing full participation due to safety or compliance concerns
- Residual toxicity grade 2 or higher from prior therapy (except alopecia)
- Inadequate organ function as defined by specified laboratory thresholds
- Significant cardiovascular disease including unstable angina, recent myocardial infarction, heart failure class II or greater, significant ECG abnormalities, uncontrolled hypertension, or LVEF below 50%
- History of uncontrolled allergic reactions or hypersensitivity to anti-HER2 antibodies or related compounds
- Pregnant or lactating women
- Receiving any other investigational agents
- For Phase 1: Received anti-cancer therapy within 28 days before first dose
- Major surgery within 28 days before first dose unless approved
- Positive for HIV
- Active or chronic hepatitis B or C except if stable and suppressed
- Any medical condition placing participant at high risk for toxicities
- Any uncontrolled intercurrent illness including infections requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
3
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
4
St Vincents Hospital, Melbourne
Fitzroy, Victoria, Australia, 3065
Not Yet Recruiting
5
GenesisCare Murdoch
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
Research Team
D
Dimitris Voliotis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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