Actively Recruiting
Actinium Therapy for Late-stage Aggressive Sarcomas
Led by Ratio Therapeutics, Inc. · Updated on 2026-03-17
30
Participants Needed
6
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Actinium Therapy for Late-stage Aggressive Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- History of relapse and refractory soft tissue sarcoma
- Histological confirmation of sarcoma at any point since diagnosis
- At least 1 prior treatment regimen
- Measurable disease by RECIST (v1.1) positive on FAPi PET/CT or PET/MRI scan
- ECOG performance status of 0 or 1
- Adequate organ reserve and renal function as shown by: neutrophil count 63 1200 �b5L without granulocyte colony stimulating factor, platelet count 63 100,000 �b5L, hemoglobin 63 8 g/dL, total bilirubin 64 1.5 �d7 upper limit of normal, AST and ALT 64 2.5 �d7 upper limit of normal, calculated creatinine clearance 63 60 mL/min, coagulation parameters 64 1.5 �d7 upper limit of normal
- Agree to use two forms of highly effective contraception if of childbearing potential
- Willing and able to provide written informed consent
You will not qualify if you...
- History of whole pelvic irradiation
- History of radioligand therapy
- Treatment within 14 days before first dose with palliative surgery, external beam radiation, approved anticancer therapy, investigational therapy, or major surgery
- Scheduled for external beam radiation or radioligand therapy during study
- Congestive heart failure greater than Class II, current pericarditis, recent myocardial infarction within 6 months, or symptomatic coronary artery disease
- Uncontrollable incontinence
- Unstable or significant concurrent medical condition endangering safety or protocol compliance
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy (except stable chronic viral disease)
- History of active fibrotic condition
- Active malignancy other than sarcoma requiring treatment
- Untreated brain or meningeal metastases (stable brain metastases allowed)
- Currently pregnant or lactating
- Known allergy to study drugs or excipients
- Unable or unwilling to comply with required imaging or study assessments
AI-Screening
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Trial Site Locations
Total: 6 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Memorial Sloane Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Case Western
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77230
Actively Recruiting
6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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