Study of CPI-100 in Patients With Advanced Tumors

Phase 1

Completed

Brief Summary: This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 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-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors

Secondary Objectives:

* To evaluate the pharmacokinetics (PK) of CPI-100

* To evaluate clinical response and resolution of symptoms after CPI-100 treatment

* To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers

Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. 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-100 within 28 days (Q2W) or 42 days (Q3W):

* 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)

Recruitment & Eligibility

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
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 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
Is pregnant or breast-feeding

Arm && Interventions

Group	Intervention	Description
CPI-100 Monotherapy	CPI-100	Dose Escalation Groups: CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
CPI-100 Combination with Capecitabine	CPI-100	CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)
CPI-100 Combination with Capecitabine	Capecitabine	CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	28 Days	• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE5

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit	through study completion, an average of 4 months	• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Adverse Effect	through study completion, an average of 4 months	• 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-100 in patients tested
Area Under the Curve (AUC)	8 Days	• To evaluate area under the curve (AUC) of CPI-100 in patients tested

Locations (2): University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
South Texas Accelerated Research Therapeutics
🇺🇸
San Antonio, Texas, United States