Status:
RECRUITING
Actinium Therapy for Late-stage Aggressive Sarcomas
Lead Sponsor:
Ratio Therapeutics, Inc.
Conditions:
Advanced Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-2...
Detailed Description
RTX-2358-101 is an open-label, seamless, Phase1/2 clinical study to evaluate safety, tolerability, dosimetry, biodistribution, pharmacokinetic (PK), and anti-tumor activity of \[Ac225\]RTX-2358. \[Ac ...
Eligibility Criteria
Inclusion
- 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 as per RECIST (v1.1) for soft tissue sarcoma that is also positive on FAPi PET/CT or PET/MRI scan.
- So keep the inclusion criteria bullet, just not include the exact definition of positive scan.
- ECOG performance status of 0 or 1.
- Adequate Organ reserve and renal function as evidenced by:
- Neutrophil count ≥ 1200 µL without granulocyte colony stimulating factor
- Platelet count ≥ 100,000 µL
- Hemoglobin ≥ 8 g/dL
- Total bilirubin level ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Calculated creatinine clearance ≥ 60 mL/min. 6. Coagulation parameters (prothrombin time, international normalized ratio and activated partial thromboplastin time) ≤ 1.5 × ULN 7. All patients (males and females of childbearing potential) must agree to practice 2 forms of highly effective contraceptive precautions to prevent pregnancy from the time consent is signed and throughout the trial.
- 8\. The patient or the patient's legal representative must be willing and able to provide written informed consent.
Exclusion
- History of whole pelvic irradiation.
- History of radioligand therapy.
- Treatment within 14 days prior to first administration with:
- Palliative surgery or external beam radiation.
- Approved anticancer therapy including chemotherapy or immunotherapy.
- Any investigational therapy.
- Any major surgery (e.g., requiring general anesthesia).
- Patients who are scheduled for external beam radiation therapy or radioligand therapy during the study period.
- Congestive heart failure \> Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease.
- Patients with uncontrollable incontinence.
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the Investigator, jeopardize the safety of a patient and/or their compliance with the protocol.
- Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy. Chronic antiviral therapy for stable viral disease can be included.
- History of active fibrotic condition.
- Any active malignancy other than sarcoma that requires treatment (.
- Currently pregnant or lactating.
- Known allergy to any of the study drugs or their excipients.- Inability or unwillingness to comply with any of the required imaging studies or study assessments.
Key Trial Info
Start Date :
November 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07156565
Start Date
November 12 2025
End Date
January 1 2032
Last Update
January 6 2026
Active Locations (3)
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1
UCLA
Los Angeles, California, United States, 90095
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Memorial Sloane Kettering Cancer Center
New York, New York, United States, 10065