Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
The expansion study is a Phase I, multicenter, open label feasibility trial to characterize
the pharmacologic activity of IV CPX-POM in bladder tumor tissues obtained from patients with
MIBC (Stage ≥T2, N0-N1, M0) who will be scheduled for RC with bilateral (standard or
extended) pelvic lymph node dissection (PLND).
The Dose Escalation study was a Phase I, multicenter, open label, dose escalation study to
evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM
administered IV in patients with any histologically- or cytologically-confirmed solid tumor
type and was completed.