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

Sponsor

Coordination Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04808453

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Advanced Tumors	Drug: CPI-300	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

accelerated titration method followed by a conventional 3 + 3 dose escalation study designaccelerated titration method followed by a conventional 3 + 3 dose escalation study design

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPI-300 Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design	Drug: CPI-300 CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Arm

Intervention/Treatment

Experimental: CPI-300

Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design

Drug: CPI-300

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

Outcome Measures

Primary Outcome Measures

Safety [28 days]
To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%

Secondary Outcome Measures

Clinical Benefit [28 Days and additional CPI-300 treatments till disease progression or intolerability]
To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Adverse Effect [28 Days and additional CPI-300 treatment till disease progression or intolerability]
To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Maximum Plasma Concentration (Cmax) [8 Days]
To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested
Area Under the Curve (AUC) [8 Days]
To evaluate area under the curve (AUC) of CPI-300 in patients tested

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
Have an ECOG performance status of 0-1
Have adequate bone marrow reserve, liver and renal function
Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

Exclusion Criteria:

Have peripheral neuropathy of Grade 3 or Grade 4 at screening
Have peripheral sensory neuropathy of Grade 2 or greater at screening
Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
Have known hypersensitivity to chemotherapeutic agents
Have chronic diarrhea
Have a history of thrombocytopenia with complications including hemorrhage or bleeding

Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe

Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment
Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
Is pregnant or breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Honor Health Research Institute	Scottsdale	Arizona	United States	85258
2	Florida Cancer Specialists	Lake Mary	Florida	United States	32746
3	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
4	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Coordination Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Coordination Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04808453

Other Study ID Numbers:

CPI-300CL21-01

First Posted:

Mar 22, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Coordination Pharmaceuticals, Inc.

Intravenous Infusion

Study Results

No Results Posted as of Jul 20, 2022