Actinium Therapy for Soft Tissue Sarcoma
(ATLAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new drug, \[Ac225\]RTX-2358, for individuals with advanced soft tissue sarcoma, a type of cancer. Researchers aim to determine if this drug can be tolerated without causing major issues and to identify the optimal dose. Participants will take the drug every 8 weeks and visit the clinic regularly for check-ups over approximately a year. This trial may suit those 18 or older whose soft tissue sarcoma has recurred or not responded to treatment. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop any approved anticancer therapy, investigational therapy, or major surgery at least 14 days before starting the study drug. If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatment \[Ac225\]RTX-2358 is being tested for safety and tolerance in people with advanced sarcoma. In earlier studies, some patients experienced manageable side effects with this type of drug, which uses a radioactive component. As these studies are still in the early stages, researchers focus on understanding safety and determining the right dose.
The trial also examines a diagnostic tool called \[Cu64\]LNTH-1363S, but the main priority is ensuring that \[Ac225\]RTX-2358 does not cause serious health issues. While specific data on side effects is not yet available, the trial's early stage means that safety remains the primary focus. Researchers closely monitor participants to understand and manage any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Actinium Therapy for soft tissue sarcoma because it represents a novel approach in cancer treatment. Unlike traditional therapies like surgery, radiation, and chemotherapy, which often have widespread effects on both cancerous and healthy cells, Actinium Therapy uses a radioactive isotope, [Ac 225]RTX-2358, to target and destroy cancer cells more precisely. This targeted approach aims to minimize damage to surrounding healthy tissue, potentially leading to fewer side effects and improved outcomes for patients. Additionally, the therapy's unique mechanism of action might offer hope for cases that are resistant to standard treatments.
What evidence suggests that Actinium Therapy might be an effective treatment for advanced sarcoma?
Research has shown that [Ac225]RTX-2358, a drug with a radioactive component, might help treat advanced sarcoma. This trial will investigate how effectively [Ac225]RTX-2358 targets and kills cancer cells in patients whose sarcoma has returned or resisted other treatments. While specific results in humans are still being gathered, the drug is designed to deliver radiation directly to the tumor, potentially reducing its size. Early findings suggest it could shrink tumors in cases where the cancer returned or resisted treatment. This method is promising because it uses targeted radiation to attack cancer cells directly.12356
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced soft tissue sarcoma that has returned after treatment. They must have had at least one prior therapy, show measurable disease on specific scans, and be in good physical condition (able to carry out daily activities). Their liver function and blood counts need to meet certain levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive escalating doses of [Ac225]RTX-2358 to determine the maximum tolerated dose. Each cycle involves a single injection followed by eight weeks of monitoring.
Treatment Phase 2
Evaluate the efficacy and safety of [Ac225]RTX-2358 on up to 50 patients.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Initial follow-up for 48 weeks, then telephone check-ins every six months for up to four years.
What Are the Treatments Tested in This Trial?
Interventions
- Actinium Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ratio Therapeutics, Inc.
Lead Sponsor