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A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

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Trial Profile

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Sep 2025

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At a glance

  • Drugs RV 01 Radiopharm Ventures (Primary)
  • Indications Advanced breast cancer; Cervical cancer; Colorectal cancer; Endometrial cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Small cell lung cancer; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Radiopharm Theranostics

Most Recent Events

  • 24 Sep 2025 Status changed from planning to not yet recruiting.
  • 28 Jul 2025 According to Radiopharm Theranostics media release, the company is on track to initiate first-in-human study of RV-01 in solid tumors in 4Q25
  • 28 Jul 2025 According to Radiopharm Theranostics media release, the company announced the the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application.

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