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

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.

Trial Details

NCT ID
NCT06305962
Phase
EARLY_PHASE1
Sponsor
Radiopharm Theranostics, Ltd
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Locations (sample)
  • Kingswood, New South Wales, Australia|-33.75614,150.72346
  • Wollongong, New South Wales, Australia|-34.424,150.89345
  • Southport, Queensland, Australia|-27.96724,153.39796
  • Adelaide, South Australia, Australia|-34.92866,138.59863
  • Murdoch, Western Australia, Australia|-32.06987,115.83757

Key Eligibility Criteria

  • Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study pr…
  • Adult participants ≥ 18 years of age.
  • Participants with a documented history of histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC,…
  • Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient o…

For full eligibility, visit ClinicalTrials.gov.

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