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HEAT Trial (HER2 Antibody Therapy With Lutetium-177) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT06824155•Radiopharm Theranostics, Ltd

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 or HER2-low, 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). 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 undergo IHC testing as determined by a validated test (tumor tissue may be obtained from archived samples or from a freshly obtained biopsy).
•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 (β-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 90 days after the last dose of 177Lu-RAD202. 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.
+15 more criteria

Exclusion Criteria

•11. For Phase 1 (Treatment Period): Participants must have positive lesion(s) by 177Lu-RAD202im SPECT/CT per central review.
•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 or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \< 60 mL/min
•* 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
+6 more criteria

Locations (5)

Nepean Hospital

Kingswood, New South Wales, Australia

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

St Vincents Hospital, Melbourne

Fitzroy, Victoria, Australia

GenesisCare Murdoch

Murdoch, Western Australia, Australia

Key Dates

Start Date

February 12, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

February 11, 2026

Enrollment

ESTIMATED participants

Conditions

HER2 Gene MutationAdvanced Solid Tumors

Interventions

177Lu-RAD202

DRUG

Contacts

Dimitris Voliotis, MD

CONTACT

+1 646 535 5017 dv@radiopharmtheranostics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

Inclusion Criteria

Exclusion Criteria

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