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Safety, MTD, and efficacy of AC-225 RTX-2358 in treatment of relapsed or refractory sarcoma

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A Seamless Phase 1/2 Open-label Study to Evaluate the Safety, Determine the Maximum Tolerated Dose of Administered Activity, and Evaluate the Efficacy of the Therapeutic Radiopharmaceutical [Ac 225]-RTX-2358 in the Treatment of Relapsed or Refractory Sarcoma

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Sarcoma

Study Purpose

The goal of this clinical trial is to learn about the safety of drug [Ac225]RTX-2358 and the diagnostic imaging agent [Cu64]LNTH-1363S. Additionally Ratio Therapeutics will learn if [Ac225]RTX-2358 drug is effective in treating advanced sarcoma. The main questions the study aims to answer in Phase/Part 1 of the trial are: - Is [Ac225]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients. - What is the most tolerable dose of [Ac225]RTX-2358 - Does the treatment show effectiveness on advanced sarcoma Participants will: - Take drug [Ac225]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months - Visit the clinic three times for the first week of cycle one, then once a week for the remaining 7 weeks of cycle 1 for check-ups and tests. - For cycles 2-6: patient will visit the clinic once every 2 weeks for checkups and tests - Remain in long term follow-up for a period of four additional years

Principal Investigator
Ankit Mangla MD
Department/Division
Cancer (Any Solid Tumor)
  • UH IRB: STUDY20250938 / Pro00088877
  • StudyID: RATI1725
  • ClinicalTrials.gov: NCT07156565
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