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New treatment option for Advanced Soft Tissue Sarcoma
Official title Actinium Therapy for Late-stage Aggressive Sarcomas
ClinicalTrials.gov ID: NCT07156565
What this study is testing
What is [Ac 225]RTX-2358?
[Ac 225]RTX-2358 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced soft tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Houston, Texas, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.