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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: 29 Apr 2026

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At a glance

  • Drugs 77-Lu 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

  • 23 Apr 2026 Results presented in the Radiopharm theranostics media release.
  • 23 Apr 2026 According to a Radiopharm theranostics media release, the company completed enrolment of the second Cohort of the Phase 1 study of RAD 204 and can proceed with dosing patients in the third Cohort with an updated dose of 90mCi of Lu177 as approved by the Data and Safety Monitoring Committee. And, the data from third cohort of patients at 90mCi of the trial are expected mid-2026.
  • 11 Feb 2026 Planned number of patients changed from 23 to 30.

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