NCT04808453

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Coordination Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	CPI-300	CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Timeline

• Start date: 2021-06-15
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2021-03-22
• Last updated: 2024-02-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study