NCT04608045

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: CicloMed LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The expansion cohort of this study was conducted at up to 3 study sites. It was 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 were scheduled for RC with bilateral (standard or extended) pelvic lymph node dissection (PLND). Both cisplatin eligible and chemotherapy eligible MIBC patients scheduled for RC were eligible to participate. Neoadjuvant treatment with CPX-POM, whether alone or in combination with gemcitabine +cisplatin, started within 8 weeks of transurethral resection of the bladder tumor (TURBT) that showed muscularis propria invasion. Nine patients, four cisplatin-ineligible, and five chemotherapy-eligible patients, were enrolled. Patients who are cisplatin-ineligible were treated with two 21-day treatment cycles of CPX-POM alone (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 received neoadjuvant chemotherapy (gemcitabine + cisplatin in three 21-day treatment cycles) in combination 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 was administered per the institution's standard of care. After each infusion of CPX-POM at the RP2D of 900 mg/m2,, patients remained in the clinic for at least a 1-hour observation period. On Day 1 of Cycle 1, single blood and clean catch urine samples were collected prior to the first CPX-POM infusion. On Day 5 of Cycle 1, serial blood and complete urine samples were collected over 24 hours following the fifth, once daily CPX-POM RP2D dose of 900 mg/m2 infused over 20 minutes.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CPX-POM	CPX-POM

Timeline

• Start date: 2019-05-19
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-10-29
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study