MC# 19-19 - A Phase I, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 via Intravenous Infusion in Patients with Advanced Solid Tumors

  • Agent(s): CPI-200
  • Disease Type(s): Solid Tumor
  • Phase(s): I
  • Drug Classification(s): Cytotoxic Therapy
  • Molecular Target(s): n/a

Mechanism of Action

CPI-200 is a nanoparticle carrying CPI-017, a prodrug of cisplatin, and CPI-018, a prodrug of paclitaxel. CPI-017 and CPI-018 are converted in vivo into cisplatin and paclitaxel, respectively.

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of CPI-200 can be given with an acceptable level of side effects
  • The effects of CPI-200 (good and bad)
  • How fast CPI-200 is removed from your body
Inclusion Criteria
  • Age >18 years
  • Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
  • Have advanced or metastatic disease refractory to standard curative or palliative therapy
  • Have measurable disease based on RECIST v1.1
  • Have an ECOG performance status of 0-1
  • Have a life expectancy of at least 12 weeks (in the opinion of the investigator)
  • Have adequate bone marrow reserve:
    • Absolute neutrophil count ≥1.5x109 cell/L
    • Platelet count ≥100x 109 cell/L
    • Hemoglobin at least ≥9.0 g/dL (transfusion is allowed to achieve hemoglobin of ≥9.0 g/dL 14-days prior to dosing
  • Have adequate liver function:
    • Total serum bilirubin no more than 1.5 x upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x ULN or ≤5.0 x ULN in case of documented hepatic metastasis
    • Alkaline phosphatase ≤ 2 x ULN (or ≤ 5 x ULN if liver involvement)
  • Have adequate renal function: glomerular filtration rate ≥60 mL/min
  • Be reasonably recovered from preceding major surgery as judged by the investigator and 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, preferably done within 1 week before Day 1 of treatment (not applicable to patients with bilateral oophorectomy and/or hysterectomy) and should not be breast feeding
  • Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential from study entry to 3 months after the last day of treatment (excluding women who are not of childbearing potential and men who have been sterilized)
Exclusion Criteria
  • Have peripheral sensory neuropathy of Grade 2 or greater at screening according to CTCAEv5
  • Have known hypersensitivity to platinum compounds and/or paclitaxel
  • Have thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 using CTCAEv5 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator
  • Have unresolved toxicity which is not recovered to baseline or ≤ grade 1 from previous treatment or previous investigational agents unless adverse events are clinically non-significant and/or stable on supportive therapy; excluding alopecia. Clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease or if > grade 1 toxicities are non-clinically relevant such as Lymphopenia. The investigator and medical monitor will discuss the eligibility of patients with baseline toxicity.
  • Have received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Cycle 1 Day 1 (C1D1) of treatment
  • Have signs or symptoms of end organ failure related to major organs fed by the circulatory system such as heart, kidneys, brain and eyes, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol
  • Have experienced any of the following within the 6-month period prior to screening that would interfere with the subject’s participation in the opinion of the treating investigator: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%
  • Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
  • Have any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
  • Have active hepatitis B or C, or human immunodeficiency virus infection
  • Is pregnant or breast-feeding
  • Is unwilling or unable to comply with study procedures during the treatment phase of the study

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT03953742

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Re: MC# 19-19