Study of CPI-100 in Patients With Advanced Tumors

Overview

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).

Full Title of Study: “A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 21, 2020

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)

Interventions

  • Drug: CPI-100
    • CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
  • Drug: Capecitabine
    • Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period

Arms, Groups and Cohorts

  • Experimental: CPI-100 Monotherapy
    • 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
  • Experimental: CPI-100 Combination with 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)

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Tolerated Dose (MTD)
    • Time Frame: 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 Measures

  • Clinical Benefit
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 8 Days
    • • To evaluate maximum plasma concentration (Cmax) of CPI-100 in patients tested
  • Area Under the Curve (AUC)
    • Time Frame: 8 Days
    • • To evaluate area under the curve (AUC) of CPI-100 in patients tested

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Coordination Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Ze-Qi Xu, Ph.D., (630) 415-5601, zq@coordinationpharma.com

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