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OncoMatch/Clinical Trials/NCT07156565

Actinium Therapy for Late-stage Aggressive Sarcomas

Is NCT07156565 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies [Ac 225]RTX-2358 for advanced soft tissue sarcoma.

Phase 1RecruitingRatio Therapeutics, Inc.NCT07156565Data as of May 2026

Treatment: [Ac 225]RTX-2358The 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

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Cannot have received: whole pelvic irradiation

History of whole pelvic irradiation.

Cannot have received: radioligand therapy

History of radioligand therapy.

Cannot have received: palliative surgery or external beam radiation

Exception: within 14 days prior to first administration

Treatment within 14 days prior to first administration with: Palliative surgery or external beam radiation.

Cannot have received: approved anticancer therapy including chemotherapy or immunotherapy

Exception: within 14 days prior to first administration

Treatment within 14 days prior to first administration with: Approved anticancer therapy including chemotherapy or immunotherapy.

Cannot have received: investigational therapy

Exception: within 14 days prior to first administration

Treatment within 14 days prior to first administration with: Any investigational therapy.

Cannot have received: major surgery

Exception: within 14 days prior to first administration

Treatment within 14 days prior to first administration with: Any major surgery (e.g., requiring general anesthesia).

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 →

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