This is a single-center, single-arm clinical study to evaluate the safety, tolerability and preliminary efficacy of \[225Ac\]Ac-FAPI-XT injection in patients with FAP-positive advanced solid tumors.
A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of \[225Ac\]Ac-FAPI-XT Injection in FAP-positive Patients With Advanced Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive \[225Ac\]Ac-FAPI-XT(XT117) administration at an interval of 6 weeks between each dose.
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGTreatment emergent adverse events
adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.
Time frame: Through study completion, assessed up to 2 years
Dose-limiting toxicity(DLT)
Incidence and severity of dose-limiting toxicities.
Time frame: Through study completion, assessed up to 2 years
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.(based on RECIST 1.1).
Time frame: Through study completion, assessed up to 2 years.
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .(based on RECIST 1.1).
Time frame: Through study completion, assessed up to 2 years.
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.
Time frame: Through study completion, assessed up to 2 years
Progression Free Survival (PFS)
PFS is defined as the interval from the date of first dosing to the date of first demonstrated disease progression, or to the last date of known progression-free condition of the patient, or to the date of death (based on RECIST 1.1).
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Time frame: Through study completion, assessed up to 2 years.