Actinium Therapy for Late-stage Aggressive Sarcomas

Prior treatment

• 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.
• 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.

Other illness

• History of whole pelvic irradiation or lung irradiation.
• History of radioligand therapy.
• Congestive heart failure \> Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease.
• 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.
• Known allergy to any of the study drugs or their excipients.
• History of pneumonitis, interstitial lung disease, chronic obstructive pulmonary disease (COPD) or other inflammatory/fibrotic pulmonary condition.

Other

• Patients with uncontrollable incontinence.
• Stable brain metastasis is allowed but documented untreated metastases to brain or meninges are excluded.
• Currently pregnant or lactating.
• Inability or unwillingness to comply with any of the required imaging studies or study assessments.

• 18 years of age or older.
• History of relapsed or 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.
• 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.