CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
CPX-POMdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04608045
NCT04608045Phase 1Completed
CompareCT.gov

A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors

CicloMed LLC·interventional·Posted Oct 29, 2020·Updated Mar 3, 2025

In Brief

A Phase 1 clinical trial evaluating CPX-POM for Advanced Solid Tumor. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The expansion study was 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 were 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 29, 2020
Enrollment StartMay 19, 2019
Primary CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.7 years ago

Interventions

CPX-POMdrug

CPX-POM