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New treatment option for HER2 Gene Mutation
Official title HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
ClinicalTrials.gov ID: NCT06824155
What this study is testing
What is 177Lu-RAD202?
177Lu-RAD202 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for her2 gene mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years and older.
- Written, voluntary, informed consent of the participants must be obtained in compliance with institutional, regional, and federal guidelines.
- Participants with histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed/refractory, locally...
- Must have at least 1 measurable target lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
You likely can't join if
- Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer...
- Participants who have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical...
- Residual toxicity Grade ≥ 2 from previously administered therapy (except for alopecia).
- Inadequate organ functions as reflected in laboratory parameters:
- Creatinine clearance or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated...
- Platelet count of \< 80 x 109/L
See the full eligibility criteria
Who can join
- Aged 18 years and older.
- Written, voluntary, informed consent of the participants must be obtained in compliance with institutional, regional, and federal guidelines.
- Participants with histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed/refractory, locally advanced not amenable to curative-intent therapy, or metastatic, with...
- Must have at least 1 measurable target lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Participants must have a life expectancy of ≥4 months in the opinion of the Investigator.
- Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or...
- WOCBP must agree to use a highly effective method of contraception during the study and for 90 days after the last dose of 177Lu-RAD202. Acceptable methods of contraception are described in Section 12.3.3 of the...
- 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...
- Participants with previously treated brain metastases are eligible to participate if:
- 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),
- Do not require steroids to treat associated neurological symptoms, and
- Participants have no history of leptomeningeal disease or spinal cord compression.
- Participants with active brain metastases untreated with brain-directed therapy such as radiotherapy, are not eligible.
- For Phase 1 (Treatment Period): Participants must have positive lesion(s) by 177Lu-RAD202im SPECT/CT per central review.
What rules you out
- 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...
- 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...
- Residual toxicity Grade ≥ 2 from previously administered therapy (except for alopecia).
- Inadequate organ functions as reflected in laboratory parameters:
- Creatinine clearance or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration...
- Platelet count of \< 80 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 upper limit of normal (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 normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin...
- 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)
- QT interval corrected for heart rate using Fridericia's formula (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%. (LVEF may be performed either by echocardiogram or other appropriate imaging modalities such as nuclear cardiac imaging (MUGA) or MRI).
- 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
- Pregnant or lactating women
- Participants who are receiving any other investigational agents The following exclusion criteria applies to participants in Phase 1 (Treatment Period):
- 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...
- Has had or is scheduled to have major surgery ≤ 28 days prior to the first dose of 177Lu-RAD202tr. Surgical procedures not considered to put participants at higher risk of AEs and/or interfere with the integrity of...
- Positive status for human immunodeficiency virus (HIV).
- 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.
- Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.
- Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Kingswood, New South Wales, Australia
- Macquarie Park, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Fitzroy, Victoria, Australia
- Murdoch, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingswood, New South Wales, Australia; Macquarie Park, New South Wales, Australia; Wollongong, New South Wales, Australia; Fitzroy, Victoria, Australia; Murdoch, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.