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RECRUITING
NCT07156565
PHASE1

Actinium Therapy for Late-stage Aggressive Sarcomas

Sponsor: Ratio Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-12

Completion Date

2032-01

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

[Ac 225]RTX-2358

\[Ac225\]RTX-2358 will be given as an intravenous injection once every 8 weeks for up to 6 doses. Each group will receive a set administered activity level (dose) of \[Ac 225\]RTX 2358 given once every 8 weeks. The first group will received the lower dose, the second group will received the mid level dose, and the third group the highest dose. A Safety Review Committee will determine when/if it is appropriate to allow the next group to proceed.

DIAGNOSTIC_TEST

[Cu64]LNTH-1363S

\[Cu64\]LNTH-1363S is a investigational radioactive diagnostic imaging agent to demonstrate that the tumor expresses Fibroblast Activation Protein. An imaging test is performed after a single injection with \[Cu64\]LNTH-1363S 13-35 days before the first administration of study drug \[AC225\]RTX-2358 to confirm that the sarcoma has FAP expression.

Locations (6)

UCLA

Los Angeles, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloane Kettering Cancer Center

New York, New York, United States

Case Western

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada