Actinium Therapy for Late-stage Aggressive Sarcomas

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ratio Therapeutics, Inc.
Study ID
NCT07156565
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [Ac 225]RTX-2358 — DRUG
    \[Ac225\]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.
  • [Cu64]LNTH-1363S — DIAGNOSTIC_TEST
    \[Cu64\]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.

Study Details

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

Key Dates

Start date
Nov 12, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with [Ac 225]RTX-2358
    The study design is a modified 3+3 with Phase 1 queue (IQ) escalating group design.

Primary Outcome Measure

Evaluate the safety (Frequency and severity of treatment emergent adverse events (TEAEs), Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and adverse events of special interest) of [Ac225-]RTX-2358 [ Time Frame: 48 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Jacqueline Banuelos
[email protected]
310-869-7014
Arun Singh, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Brittany Siontis, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloane Kettering Cancer CenterNew YorkNew York10065
Sandra D'Angelo, MD
[email protected]
646-392-1037
Sandra D'Angelo, MD (PRINCIPAL_INVESTIGATOR)
Case WesternClevelandOhio44106
Ankit Mangla, MD
[email protected]
216-844-3951
Ankit Mangla, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77230
Fiona Ouyang
[email protected]
713-470-8008
Michael Nakazawa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAMayo Clinic· Rochester, MNMemorial Sloane Kettering Cancer Center· New York, NYCase Western· Cleveland, OHMD Anderson Cancer Center· Houston, TX

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