NCT03953742

Study of CPI-200 in Patients With Advanced Tumors

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
• 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-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)

Detailed 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

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CPI-200	CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-02-01
• Completion: 2022-02-15
• First posted: 2019-05-17
• Last updated: 2022-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study