Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

History of relapsed or 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 or lung irradiation.

History of radioligand therapy.

Palliative surgery or external beam radiation.

Approved anticancer therapy including chemotherapy or immunotherapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • [Ac 225]RTX-2358

    Drug

    \[Ac225\]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.

  • [Cu64]LNTH-1363S

    Diagnostic test

    \[Cu64\]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 14-30 days before the first administration of study drug \[AC225\]RTX-2358 to confirm that the sarcoma has FAP expression.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Treatment with [Ac 225]RTX-2358Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Evaluate the safety (Frequency and severity of treatment emergent adverse events (TEAEs), Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and adverse events of special interest) of [Ac225-]RTX-2358

Frequency and severity of treatment emergent adverse events (TEAEs), Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and adverse events of special interest (AESIs).

Time frame
48 weeks
2

Evaluate the preliminary anti-tumor activity of [Ac225]RTX-2358 in patients with relapsed or refractory soft tissue sarcoma

Objective response rate (ORR), defined as the proportion of patient with a complete response (CR) or partial response (PR), per RECISTv1.1. Duration of response (DOR) defined as the duration of time from first date of observed response (CR or PR), to first date of disease progression or death from any cause.

Time frame
48 weeks
3

Determine the MTD of the administered activity of [Ac-225]RTX-2358 and select the administered activity and schedule for further clinical evaluation

Evaluate dose levels in Phase 1 escalating group design to identify the MTD and the administered activity to be used in the expansion cohort

Time frame
8 weeks

Secondary outcomes

1

Further evaluate the preliminary efficacy of [Ac225]RTX-2358 in patients with relapsed or refractory soft tissue sarcoma

Duration of progression-free survival (PFS): the duration of time from first treatment administration to first date of disease from any cause.

Time frame
Up to 5 years
2

Further evaluate the preliminary efficacy of [Ac225]RTX-2358 in patients with relapsed or refractory soft tissue sarcoma

Overall Survival (OS): the duration of time from first treatment administration to date of death from any cause.

Time frame
Up to 5 years
3

Determine the normal tissue radiation dosimetry of [Ac225]RTX-2358

Radiation absorbed dose estimates for selected normal tissues. Analysis of radioactive blood samples for select timepoints

Time frame
Days 1, 3, 8, and Week 4
4

Determine the maximum concentration (Cmax) of radiation (Pharmacokinetics) in the blood after a single dose of [Ac225]RTX-2358

Blood samples will be collected Pre-dose, immediately post-dose, 15 minutes, 30 minutes, 60 minutes, 4 hours, Day 3, Day 8, and 4 weeks post dose. Radiation (PK) to be measured by gamma counter (KBq/mL).

Time frame
Up to 4 weeks post injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ratio Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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