SJELiOT is a Phase 1 treatment study evaluating prexasertib, a CHK1/2 inhibitor, in combination with DNA-damaging chemotherapy for children and adolescents with recurrent/refractory Group 3, Group 4, or SHH medulloblastoma.
Participants are allocated to one of two strata: Stratum A: prexasertib plus cyclophosphamide; Stratum B: prexasertib plus gemcitabine. The primary objectives are to determine safety and tolerability, estimate the maximum tolerated dose / recommended Phase 2 dose, and characterise prexasertib pharmacokinetics in each combination. Secondary objectives include objective response, duration of response, progression-free survival, and pharmacokinetics of the combination agents.