Actinium Therapy for Late-stage Aggressive Sarcomas

Inclusion Criteria

• 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.
• The patient or the patient's legal representative must be willing and able to provide written informed consent.

Exclusion Criteria

• 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.