ATLAS

Actinium Therapy for Late-stage Aggressive Sarcomas (ATLAS)

Agent: [Ac-225] RTX-2358,
Diagnostic test: [Cu64]LNTH-1363S
Phase I/II
Status Recruiting
Sponsor Ratio Therapeutics, Inc.

 

For further information please also consult https://www.clinicaltrials.gov/study/NCT07071727

This is a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, dosimetry, biodistribution, pharmacokinetics, and preliminary anti-tumor activity of [Ac-225] RTX-2358 in patients with advanced soft tissue sarcoma.

[Ac-225] RTX-2358 is a highly selective, FAP targeted radiopharmaceutical therapy. It combines a molecule that binds to tumor-associated targets with the radioactive isotope Actinium-225, which delivers radiation directly to cancer cells.

[Cu-64] LNTH-1363S is a PET imaging agent used to identify patients whose tumors express the relevant target (FAP) and to monitor how the drug distributes in the body.

 

WHO is the trial for?
  • Adult patients (18 years or older)
  • Histologically confirmed advanced or metastatic soft tissue sarcoma
  • Disease that has progressed after at least one prior systemic therapy
  • Adequate organ function and overall health status
  • Tumor must demonstrate the relevant target on PET imaging

Additional medical eligibility criteria apply and are reviewed by the study team

WHAT is the key question that this trial is attempting to answer?

 Is [Ac225]RTX-2358 safe and effective in treating patients with advanced soft tissue sarcoma? What is the best tolerable dose?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the US and Canada.

For further information check here.

Contact :
Ratio Therapeutics, Inc.

STUDY DESIGN: What does the study look like?

 Before the first administration of the study drug, a diagnostic test will be performed:

[Cu64]LNTH-1363S is an investigational radioactive imaging agent used to determine if the tumor expresses fibroblast activation protein (FAP). An imaging test is performed 13-35 days after a single injection of [Cu64]LNTH-1363S, to confirm FAP expression in the sarcoma.

Treatment phase:

  • Phase 1/2 open-label trial (no placebo group).
  • Dose-escalation phase: small groups receive increasing doses of [Ac225] RTX-2358 to determine safety.
  • Dose-expansion phase: additional participants treated at the selected dose.
  • Treatment administered intravenously every 8 weeks.
  • Up to 4 planned treatment cycles (maximum 6 cycles) over a period of 12 months.
  • Long-term follow-up for safety and disease monitoring (up to approximately 4 years).

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken