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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06824155




Registration number
NCT06824155
Ethics application status
Date submitted
7/02/2025
Date registered
25/03/2025

Titles & IDs
Public title
HEAT Trial (HER2 Antibody Therapy with Lutetium-177)
Scientific 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
Secondary ID [1] 0 0
RAD202.2022.0002
Universal Trial Number (UTN)
Trial acronym
RAD202
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 Gene Mutation 0 0
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 177Lu-RAD202

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


Treatment: Drugs: 177Lu-RAD202
177Lu-RAD202 administered at Imaging (im) and Treatment (tr) doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time Activity Curves (TACs)
Timepoint [1] 0 0
72 hours
Primary outcome [2] 0 0
Radiation dosimetry of Lu177-RAD202im
Timepoint [2] 0 0
72 hours
Primary outcome [3] 0 0
Safety and tolerability of a single dose of 177Lu-RAD202tr
Timepoint [3] 0 0
6 weeks
Primary outcome [4] 0 0
Recommended dose(s) of 177Lu-RAD202tr for future exploration
Timepoint [4] 0 0
6 weeks
Primary outcome [5] 0 0
Pharmacokinetics of 177Lu-RAD202im
Timepoint [5] 0 0
72 hours
Primary outcome [6] 0 0
Biokinetics of 177Lu-RAD202im
Timepoint [6] 0 0
72 hours
Secondary outcome [1] 0 0
Safety and tolerability of 177Lu-RAD202im
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Recommended dose(s) of 177Lu-RAD202im for future exploration
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Preliminary antitumor activity of 177Lu-RAD202tr
Timepoint [3] 0 0
Up to 30 weeks
Secondary outcome [4] 0 0
Radiation dosimetry of 177Lu-RAD202tr
Timepoint [4] 0 0
72 hours

Eligibility
Key inclusion criteria
1. Aged 18 years and older.
2. Written, voluntary, informed consent of the participants must be obtained in compliance with institutional, regional, and federal guidelines.
3. Participants with histologically or cytologically confirmed, HER2 positive advanced solid tumours that are relapsed/refractory, locally advanced not amenable to curative-intent therapy, or metastatic, with documented disease progression during or after their most recent line of anti-cancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit.

Participant HER2 positivity is determined by local testing and is defined as a score of 3+ on immunohistochemical analysis IHC), or, defined as a score of 2+ on IHC and positive results on in situ hybridisation (ISH).
4. Must have at least 1 measurable target lesion according to RECIST version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status =2.
6. Participants must have a life expectancy of =4 months in the opinion of the Investigator.
7. Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (ß-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
8. WOCBP must agree to use a highly effective method of contraception during the study and for 60 days after the last dose of 177Lu-RAD202 (60 days is approximately 10 physical half-lives of 177Lu and >480 effective half-lives of NM-02DOTAGA). Acceptable methods of contraception are described in Section 12.3.3 of the Protocol.
9. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 90 days after the last dose of 177Lu-RAD202. All male participants must agree to not donate sperm during the study and at least 14 days after the last injection of 177Lu-RAD202im and/or 90 days after the last dose of 177Lu-RAD202tr, whichever occurs later. Acceptable methods of contraception are described in Section 12.3.3 of the Protocol.
10. Participants with previously treated brain metastases are eligible to participate if:

1. They are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality [magnetic resonance imaging (MRI) or computed tomography (CT) scan] must be used for each assessment),
2. Do not require steroids to treat associated neurological symptoms, and
3. Participants have no history of leptomeningeal disease or spinal
11. For Phase 1 (Treatment Period): Participants must have positive lesion(s) by 177Lu-RAD202im SPECT/CT per central review.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
2. Participants who have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time-point imaging procedures, etc.
3. Residual toxicity Grade = 2 from previously administered therapy (except for alopecia).
4. Inadequate organ functions as reflected in laboratory parameters:

* Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min
* Platelet count of < 100 x 109/L
* Absolute neutrophil count (ANC) < 1.5 x 109/L
* Haemoglobin < 9 g/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases
* Total bilirubin > 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin = 3 x ULN
* For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) =1.5 or prothrombin time (PT) =1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) =1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR <3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.
5. Significant cardiovascular disease including:

* Unstable angina and/or myocardial infarction within 6 months prior to screening
* New York Heart Association Class II or greater congestive heart failure
* Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)
* QTcF > 470 msec for females and QTcF > 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome
* Uncontrolled hypertension
* Known LVEF < 50%
6. History of uncontrolled allergic reactions and/or have hypersensitivity to anti-HER2 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity
7. Pregnant or lactating women
8. Participants who are receiving any other investigational agents

The following exclusion criteria applies to participants in Phase 1 (Treatment Period):
9. Major surgery within 4 weeks prior to first dose of 177Lu-RAD202tr. Exceptions may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
10. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD202tr.
11. Has had or is scheduled to have major surgery =28 days prior to the first dose of 177Lu-RAD202tr. Elective surgical procedures not considered to put participants at higher risk of AEs may be allowed on a case-by-case basis in discussion with the Sponsor.
12. Positive status for human immunodeficiency virus (HIV).
13. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.
14. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.
15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
GenesisCare Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Radiopharm Theranostics, Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dimitris Voliotis, MD
Address 0 0
Country 0 0
Phone 0 0
+1 646 535 5017
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06824155