Phase I Study of CPI-300 in Patients With Advanced Tumors — CPI-300  

Advanced Tumors Clinical Trial

Official title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).

Clinical Trial Description

Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days:

• Grade 4 or greater treatment related adverse events

• Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)

Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment. ;

Related Conditions & MeSH terms

• Advanced Tumors

• NCT number: NCT04808453
• Study type: Interventional
• Source: Coordination Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2021
• Completion date: December 15, 2023