Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The expansion cohort of this study will be conducted at up to 3 study sites. It will be an 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). Approximately half of the patients enrolled will be cisplatin eligible and half will be chemotherapy eligible and scheduled to receive neoadjuvant chemotherapy with gemcitabine + cisplatin. Neoadjuvant treatment with CPX-POM, whether alone or in combination with gemcitabine +cisplatin, will start within 8 weeks of transurethral resection of the bladder tumor (TURBT) that showed muscularis propria invasion.

Approximately 12 patients will be enrolled. Patients who are cisplatin eligible will be treated with two 21-day treatment cycles of CPX-POM (Cycle 1, Days 1-5 treatment, rest days 6-21; Cycle 2, Days 22-26 treatment, rest days 27-43) before a planned RC. Chemotherapy-eligible patients who are scheduled to receive neoadjuvant chemotherapy (gemcitabine + cisplatin in three 21-day treatment cycles) will be treated in addition with three 21-day treatment cycles of CPX-POM (Cycle 1, Days 1-5 treatment, rest days 6-21; Cycle 2, Days 22-26 treatment, rest days 27-42; Cycle 3, Days 43-47, rest days 48-63), i.e. concurrently with the prescribed chemotherapy. The cisplatin + gemcitabine dosing regimen for chemotherapy-eligible patients in the Expansion Cohort will be administered per the institution's standard of care. After each infusion of CPX-POM, patients will remain in the clinic for at least a 1-hour observation period. On Day 1 of Cycle 1, single blood and clean catch urine samples will be collected prior to the first CPX-POM infusion. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

• NCT number: NCT04608045
• Study type: Interventional
• Source: CicloMed LLC
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2019
• Completion date: April 30, 2023