Study of CPI-200 in Patients With Advanced Tumors

Advanced Solid Tumor Clinical Trial

Official title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 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-200 in patients with advanced tumors. CPI-200 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

Primary Objectives:

• To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors

Secondary Objectives:

• To evaluate the pharmacokinetics (PK) of CPI-200

• To evaluate clinical response and resolution of symptoms after CPI-200 treatment

• To characterize adverse events of CPI-200 in patients with advanced cancers

Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:

• All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness

• Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria

• Grade 3 thrombocytopenia in the presence of bleeding

• Grade 3 or greater febrile neutropenia

• Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment ;

Related Conditions & MeSH terms

• Advanced Solid Tumor

• NCT number: NCT03953742
• Study type: Interventional
• Source: Coordination Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Completion date: February 15, 2022