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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: 04 Dec 2025

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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

  • 12 Nov 2025 According to a Radiopharm theranostics media release, the company announced the completion of enrollment for the second cohort of patients in this trial .
  • 20 Oct 2025 According to a Radiopharm theranostics media release, The Company recently completed dosing in its first cohort of patients at 30mCi and in the second cohort dose level of 60mCi meeting with the DSMC is scheduled to approve further dose escalation to the third dose level.
  • 20 Oct 2025 Results (n= 6) presented in the Radiopharm theranostics media release.

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