RecruitingEarly Phase 1NCT06305962

177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Solid Tumours

Sponsor

Radiopharm Theranostics, Ltd

Enrollment

30 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

PDL1 Gene Mutation

Summary

This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration. The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new radioactive drug (177Lu-anti-PD-L1) that delivers targeted radiation directly to cancer cells that carry a specific immune checkpoint protein (PD-L1). It is being tested in people with advanced solid tumors that have not responded to other treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with one of these advanced, treatment-resistant cancers: non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer, melanoma, head and neck squamous cell carcinoma, endometrial cancer, or any cancer that is MSI-high or mismatch repair deficient - Your cancer has progressed on or you have refused standard treatments, including PD-1/PD-L1 immunotherapy **You may NOT be eligible if...** - Your cancer type is not on the qualifying list - You have not yet tried standard therapies - You have organ function or health issues that make you ineligible based on detailed study criteria Talk to your doctor to see if this trial is right for you.

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

DRUG177Lu-RAD204

177Lu-RAD204 administered at Imaging (im) and Treatment (tr) doses

Locations(5)

Nepean Hospital

Kingswood, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Cancer Research SA (CRSA)

Adelaide, South Australia, Australia

GenesisCare Murdoch

Murdoch, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06305962