Human Epidermal Growth Factor Receptor 2 (HER2) Antibody Therapy with Lutetium-177 in Patients with Advanced Solid Tumours.
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.
Radiopharm Theranostics Ltd
24 participants
Jun 3, 2025
Interventional
Conditions
Summary
This study is evaluating the safety and properties of 177Lu-RAD202, a single-domain antibody joined to a radioactive lutetium isotope targeting HER2-expressing solid tumours. You may be eligible for this study if you are an adult patient with HER2 positive advanced solid tumours that is refractory to or intolerant of standard of care treatment or have no standard of care treatment available that is likely to provide clinical benefit., Participants will undergo a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and receiving a single injection of 177Lu-RAD202. If they are able to tolerate this and show positive uptake in the following 2 week period, they will then proceed to a Phase I (Treatment) Period where they will be assigned a gradual increase of 177Lu-RAD202 dose delivered every 6 weeks for 3 cycles. Blood sampling and imaging studies will be performed to determine how the participant is responding to 177Lu-RAD202. Additional treatment cycles (beyond 3 cycles) will be considered if participant is deemed to receive clinical benefit from 177Lu-RAD202 and approved by study Sponsor. Findings from this study will help determine a recommended dose of 177Lu-RAD202 for future exploration
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This study involves the use of investigational compound, 177Lu-RAD202 in patients with HER2 positive advanced solid tumours. There will be 2 different phases in this study whereby Phase 0 (Imaging period) using 10 mCi of 177Lu-RAD202 and Phase I (treatment period) where 2 different dose levels (30 mCi and 40mCi) of 177Lu-RAD202 will be explored. The investigational product/IP (177Lu-RAD202) given during Phase 0 will be indicated as 177Lu-RAD202im while the IP given during Phase 1 (treatment period) will be indicated as 177Lu-RAD202tr. For Phase 0, after undergo screening, if patient is deemed eligible, they will be taking 1 dose of 10mCi of 177Lu-RAD202im and if they tolerate the study drug after 2 weeks and show positive uptake of 177Lu-RAD202im (i.e. 177Lu-RAD204im is being taken in by the tumour cells), they can roll-over to Phase 1 where patient will receive either 30mCi (dose level 1) or 40mCi (dose level 2) of 177Lu-RAD202tr every 6 weeks with for 3 cycles. Further treatment cycle will be considered if investigator deems that patient is receiving benefit from study drug, with sponsor approval. Only patient from Phase 0 is allowed to roll over to Phase 1. The 2 dose levels for Phase 1 have been pre-determined as 30mCi and 40mCi. The dose escalation/ de-escalation for this study will follow a BOIN design where Cohort 1 patients will receive 30mCi for their treatment dose. DSMC (Data Safety Monitoring Committees) will determine on the opening of Cohort 2 (40mCi) after reviewing data from Cohort 1 patient. 177Lu-RAD202 will be administered as intravenous (IV) bolus injection under the supervision of the study Investigator or appropriately qualified delegate. Patient medical record will be used to monitor adherence to the intervention. The continuous safety evaluation will be performed by sponsor, medical monitor, the investigators. A DSMB (Data Safety Monitoring Board) or equivalent committee will be established for the determination of dose escalation and monitoring of dose-limiting toxicity (DLT) for all patients who received 177Lu-RAD202.
Locations(4)
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ACTRN12625000191493