The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \[177Lu\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options.
\[177Lu\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.
Male or female participants ≥ 18 years of age on the day of signing informed consent.
Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Life expectancy ≥ 3 months.
Unstable systemic disease (including but not limited to active infection, hepatic, renal, or metabolic disease).
Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2).
LVEF of < 50%, as determined by MUGA or ECHO.
Uncontrolled hypertension, defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.