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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Aug 2025

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At a glance

  • Drugs RAD 204 (Primary)
  • Indications Advanced breast cancer; Carcinoma; Endometrial cancer; Head and neck cancer; Male breast cancer; Malignant melanoma; Non-small cell lung cancer; Skin cancer; Small cell lung cancer; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Radiopharm Theranostics

Most Recent Events

  • 29 Jul 2025 According to a Radiopharm theranostics media release, the second cohort is expected to be fully enrolled in the coming weeks, with expansion to multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Results from the first two cohorts of the Phase 1 study are anticipated in the second half of 2025.
  • 29 Jul 2025 According to a Radiopharm theranostics media release, In May 2025, company reported that the independent Data and Safety Monitoring Committee (DSMC) approved proceeding with Cohort 2 of the Phase 1 study of 177Lu-RAD204 at a higher dose of 60 mCi, up from the originally planned 40 mCi.
  • 21 Mar 2025 The protocol has been amended to change in phase with change in Patient Inclusion Criteria now SCLC, TNBC, cutaneous melanoma, HNSCC, and endometrial cancer will be recruited.

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