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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Actinium Therapy for Late-stage Aggressive Sarcomas

A Seamless Phase 1/2 Open-label Study to Evaluate the Safety, Determine the Maximum Tolerated Dose of Administered Activity, and Evaluate the Efficacy of the Therapeutic Radiopharmaceutical [Ac 225]-RTX-2358 in the Treatment of Relapsed or Refractory Sarcoma

Actinium Therapy for Late-stage Aggressive Sarcomas (NCT07156565) is a Phase 1 interventional studying Advanced Soft Tissue Sarcoma, sponsored by Ratio Therapeutics, INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Soft Tissue Sarcoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 years of age or older. - History of relapse and refractory soft tissue sarcoma. 1. Histological confirmation of sarcoma at any point since diagnosis 2. 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. - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. - Adequate Organ reserve and renal function as evidenced by: 1. Neutrophil count ≥ 1200 µL without granulocyte colony stimulating factor 2. Platelet count ≥ 100,000 µL 3. blood count (hemoglobin) at least 8 g/dL 4. Total bilirubin level ≤ 1.5 × upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 6. Calculated kidney function (creatinine clearance) at least 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 willing to sign a consent form. Who Should NOT Join This Trial: - History of whole pelvic irradiation. - History of radioligand therapy. - Treatment within 14 days prior to first administration with: 1. Palliative surgery or external beam radiation. 2. Approved anticancer therapy including chemotherapy or immunotherapy. 3. Any investigational therapy. 4. Any major surgery (e.g., requiring general anesthesia). - Patients who are scheduled for external beam radiation therapy or radioligand therapy during the study period. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 18 years of age or older. * History of relapse and refractory soft tissue sarcoma. 1. Histological confirmation of sarcoma at any point since diagnosis 2. 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: 1. Neutrophil count ≥ 1200 µL without granulocyte colony stimulating factor 2. Platelet count ≥ 100,000 µL 3. Hemoglobin ≥ 8 g/dL 4. Total bilirubin level ≤ 1.5 × upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 6. 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 Criteria: * History of whole pelvic irradiation. * History of radioligand therapy. * Treatment within 14 days prior to first administration with: 1. Palliative surgery or external beam radiation. 2. Approved anticancer therapy including chemotherapy or immunotherapy. 3. Any investigational therapy. 4. 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. * Stable brain metastasis is allowed but documented untreated metastases to brain or meninges are excluded. * 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.

Treatments Being Tested

DRUG

[Ac 225]RTX-2358

\[Ac225\]RTX-2358 will be given as an intravenous injection once every 8 weeks for up to 6 doses. Each group will receive a set administered activity level (dose) of \[Ac 225\]RTX 2358 given once every 8 weeks. The first group will received the lower dose, the second group will received the mid level dose, and the third group the highest dose. A Safety Review Committee will determine when/if it is appropriate to allow the next group to proceed.

DIAGNOSTIC_TEST

[Cu64]LNTH-1363S

\[Cu64\]LNTH-1363S is a investigational radioactive diagnostic imaging agent to demonstrate that the tumor expresses Fibroblast Activation Protein. An imaging test is performed after a single injection with \[Cu64\]LNTH-1363S 13-35 days before the first administration of study drug \[AC225\]RTX-2358 to confirm that the sarcoma has FAP expression.

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UCLA
Los Angeles, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloane Kettering Cancer Center
New York, New York, United States
Case Western
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07156565), the sponsor (Ratio Therapeutics, INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07156565 clinical trial studying?

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 ever… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07156565?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07156565?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07156565. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07156565. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.