MC# 19-39 - An Open Label, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 in Adult Patients with Metastatic Solid Tumors; A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study

  • Agent(s): TAK-573
  • Disease Type(s): Prostate, Solid Tumor, Lung-NSCLC
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Monoclonal Antibody
  • Molecular Target(s): CD38

Mechanism of Action

TAK-573 targets and binds to CD38 on CD38-positive tumor cells.  In turn, the IFNa moiety binds to cell-surface IFN receptors, and activates IFN-mediated signal transduction pathways, which results in the transcription and translation of genes whose products may cause antiproliferative effects in CD38-positive tumor cells.

Purpose

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

  • How much of TAK-573 can be given with an acceptable level of side effects
  • About the safety and tolerability of TAK-573
  • How proteins that indicate the status of your disease are affected with use of TAK-573
  • How much of TAK-573 is absorbed into the blood and how fast it is removed
  • If your body develops proteins that work against TAK-573
  • If research tests can be used in the future to predict who will benefit from TAK-573
  • If TAK-573 prevents or delays tumor growth
Inclusion Criteria
  1. Adult male or female patients aged ≥18 years
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  3. For both the dose escalation and expansion cohort phases of the study, eligible patients must have histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapeutic option, are intolerant to these therapies, or have refused them
    • For the expansion cohort phase of the study, eligible patients must also have 1 of the following:
      • NSCLC
      • CRPC
      • Other solid tumors that have progressed after previous treatment containing a CPI
  4. Measurable disease per mRECIST v1.1.  At least 1 target lesion amenable for biopsy is required for enrollment in the dose escalation phase, and 2 target lesions are required for enrollment in the dose expansion phase (1 for biopsy and at least 1 for response assessment)
  5. Female patients who:
    • Are postmenopausal for at least 1 year before the screening visit, OR
    • Are surgically sterile, OR
    • If they are of childbearing potential:
      • Agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, OR
      • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea  are not acceptable methods of contraception.  Female and male condoms should not be used together.)
      • Agree not to donate an egg or eggs (ova) during the study and for 30 days after the last dose of study drug
  6. Male patients, even if surgically sterilized (ie, status postvasectomy), who:
    • Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.  Female and male condoms should not be used together.)
  7. Patients must agree to have a new (fresh) tumor biopsy during the screening period and on C2D2.  Patients with CRPC without visceral disease are excluded from this requirement.
Exclusion Criteria
  1. Treatment with any investigational products within 28 days before the first dose of study drug or 4 half-lives, whichever is shorter
  2. History of any of the following ≤6 months before first dose: New York Heart Association Grade III or IV congestive heart failure, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing symptomatic cardiac arrhythmias of Grade >2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, symptomatic pericardial effusion or restrictive cardiomyopathy).  Chronic, stable atrial fibrillation on stable anticoagulant therapy, including low molecular- weight heparin, is allowed.
  3. Baseline QTcF >480 msec (Grade ≥2), history of congenital long QT syndrome, or torsades de pointes
  4. Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events (AEs) or has compromised ability to provide written informed consent
  5. Ongoing or active infection
  6. Known history of HIV infection or any other relevant congenital or acquired immunodeficiency.  Testing during screening period is required only if indicated by specific local regulations or investigator's criteria.
  7. Known hepatitis B (HBV) surface antigen seropositive or detectable hepatitis C infection viral load.  Testing during screening period is required only if indicated by local regulations or investigator's criteria.
  8. Note: Patients who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable hepatitis B viral load
  9. Autoimmune disease requiring systemic immunosuppressive therapy.  The following are exceptions to this criterion: vitiligo, alopecia, endocrine insufficiency on stable hormone replacement, psoriasis, or eczema not requiring systemic treatment.

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT04157517

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Re: MC# 19-39