OncoMatch/Clinical Trials/NCT07156565
Actinium Therapy for Late-stage Aggressive Sarcomas
Is NCT07156565 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies [Ac 225]RTX-2358 for advanced soft tissue sarcoma.
Treatment: [Ac 225]RTX-2358 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Sarcoma
Biomarker criteria
Required: FAP imaging positive
Measurable disease as per RECIST (v1.1) for soft tissue sarcoma that is also positive on FAPi PET/CT or PET/MRI scan
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anticancer therapy
At least 1 prior treatment regimen
Cannot have received: whole pelvic irradiation
History of whole pelvic irradiation
Cannot have received: lung irradiation
History of lung irradiation
Cannot have received: radioligand therapy
History of radioligand therapy
Lab requirements
Blood counts
Neutrophil count ≥ 1200/µL without G-CSF; Platelet count ≥ 100,000/µL; Hemoglobin ≥ 8 g/dL; Coagulation parameters (PT, INR, aPTT) ≤ 1.5 × ULN
Kidney function
Calculated creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin level ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN
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 × ULN; AST and ALT ≤ 2.5 × ULN; Calculated creatinine clearance ≥ 60 mL/min; Coagulation parameters (PT, INR, aPTT) ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA · Los Angeles, California
- Mayo Clinic · Rochester, Minnesota
- Memorial Sloane Kettering Cancer Center · New York, New York
- Case Western · Cleveland, Ohio
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07156565 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior whole pelvic irradiation, lung irradiation, radioligand therapy disqualifies patients from enrollment.
Does this trial require FAP?
Yes, FAP imaging positive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages