Actinium Therapy for Late-stage Aggressive Sarcomas
ConditionAdvanced Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRatio Therapeutics, Inc.
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
Eligibility criteria
Qualifiers
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
Disqualifiers
History of whole pelvic irradiation.
History of radioligand therapy.
Palliative surgery or external beam radiation.
Approved anticancer therapy including chemotherapy or immunotherapy.
Trial design
Treatments tested in this trial
- [Ac 225]RTX-2358
- [Cu64]LNTH-1363S
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov