Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [Ac 225]RTX-2358
RTX-2358 · 1 trial · 1 indication
Frequency and severity of treatment emergent adverse events (TEAEs), Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and adverse events of special interest (AESIs).
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.
Evaluate dose levels in Phase 1 escalating group design to identify the MTD and the administered activity to be used in the expansion cohort
| Arm | Type | Description |
|---|---|---|
| Treatment with [Ac 225]RTX-2358 | EXPERIMENTAL | The study design is a modified 3+3 with Phase 1 queue (IQ) escalating group design. |
| Name | Type | Description |
|---|---|---|
| [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. |
Inclusion Criteria: * 18 years of age or older. * History of relapsed or refractory soft tissue sarcoma. 1. Histological confirmation of sarcoma at any point since diagnosis 2. At least 1 prior treatment regimen * Measurable disease as per RECIST (v1.1) for soft tissue sarcoma that is also pos...