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A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors

NCT02642016

Description:

This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors

Title

  • Brief Title: A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors
  • Official Title: A Phase 1, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KTN0158 in Adult Patients With KIT Positive Advanced Solid Tumors.
  • Clinical Trial IDs

    NCT ID: NCT02642016

    ORG ID: KTN0158-CL-001

    Trial Conditions

    Advanced Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose
    (MTD) and/or recommended Phase 2 dose, and the safety profile of KTN0158 in patients with
    KIT-positive advanced solid malignancies refractory to standard therapy or for which no
    standard therapy exists.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    KTN0158 Experimental KTN0158

    Eligibility Criteria

    Inclusion Criteria:

    1. Written informed consent and any locally required authorization (eg, HIPAA in the
    USA) obtained from the patient/legal representative prior to performing any
    protocol-related procedures, including screening evaluations.

    2. Metastatic or unresectable cancer that expresses KIT. KIT expression must have been
    documented in the patient's pathology report. Other patients with KIT positive
    cancers will have progressed on at least one prior therapy.

    3. For patients with GIST, patients will have progressed on at least one prior tyrosine
    kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or
    PDGFRA-D842V GIST, no prior therapy is required for study entry.

    4. Patients must have at least 1 lesion that is measurable using Response Evaluation
    Criteria in Solid Tumors (RECIST) guidelines (v 1.1; Eisenhauer et al, 2009).

    5. Age 18 years at the time of study entry.

    6. Females must be surgically sterile, one year post menopausal or negative results for
    a pregnancy test performed at Screening and agree to use two methods of
    contraception; Males who have not had a vasectomy must agree to two methods of
    contraception.

    7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 (see Appendix 2).

    8. Adequate organ function as defined below:

    - Hemoglobin 10 g/dL. This criterion must be met without transfusion.

    - Absolute neutrophil count 1500/mm3

    - Platelet count 100,000/mm3

    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 5
    institutional upper limit of normal (ULN) for cases involving liver metastasis
    and 2.5 ULN for all other cases

    - Bilirubin 1.5 ULN except for cases of documented or suspected Gilbert's
    disease, in which bilirubin must be 5 ULN

    - Serum creatinine 1.5 g/dL

    Exclusion Criteria:

    1. Receipt of anticancer therapy:

    - Within 3 weeks prior to the first dose of KTN0158 of any biologic treatment or
    IV chemotherapy.

    - Within 2 weeks prior to the first dose of KTN0158 of any oral therapy or 5.5
    half lives whichever is longer or following palliative radiation therapy.

    2. Concurrent use of hormones for non-cancer related conditions (eg, insulin for
    diabetes and hormone replacement therapy) is acceptable. Concurrent use of
    gonadotropin-releasing hormone agonists for prostate cancer is acceptable if the
    patient has been on a stable dose for at least 3 months prior to the first dose of
    KTN0158.

    3. Immunosuppressive or systemic steroids medication within 7 days before the first dose
    of KTN0158 (inhaled and topical corticosteroids are permitted). Concurrent use of
    replacement doses of steroids (defined as 30 mg/day hydrocortisone or the
    equivalent) is acceptable if the patient has been on a stable dose for at least 2
    weeks prior to the first dose of KTN0158.

    4. Known allergy or past administration reaction including infusion reactions,
    anaphylactic, or anaphylactoid reactions to any component of the KTN0158 formulation.

    5. Symptomatic or untreated central nervous system metastases requiring concurrent
    treatment, including but not limited to surgery, radiation, and/or corticosteroids;
    if treated, patient must be asymptomatic for 3 months prior to study entry.

    6. Other invasive malignancy within 2 years prior to enrollment except for localized
    prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin,
    or ductal carcinoma in situ of the breast that has/have been surgically cured.

    7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved
    to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
    CTCAE) v 4.03 < Grade 2 or normalized to baseline, or to levels dictated in the
    inclusion/exclusion criteria, with the exception of alopecia.

    8. Major surgical procedure (as defined by the investigator) within 30 days prior to
    Study Day 1 or incomplete recovery from any prior surgery.

    9. Pregnancy or breast feeding

    10. Uncontrolled intercurrent illness that would limit compliance with study requirements
    or compromise the patient such as ongoing or active infection, symptomatic congestive
    heart failure, hypertension requiring adjustment of medication, idiopathic and
    symptomatic hypotension, unstable angina pectoris, clinically significant cardiac
    arrhythmia including atrial fibrillation, active peptic ulcer disease or gastritis
    with ongoing blood loss, or psychiatric illness/social situations that would limit
    compliance with study requirements or compromise the ability of the patient to give
    written informed consent.

    11. Any condition that, in the opinion of the investigator, would interfere with
    evaluation of the investigational product or interpretation of patient safety or
    study results.

    12. Concurrent enrollment in another clinical study, unless it is an observational
    (non-interventional) study.

    13. Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an
    echocardiogram or MUGA scan or prolonged QTc interval of Grade 2 or higher or history
    of prolonged QTc interval from other drugs.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Dose limiting toxicities for KTN0158

    Secondary Outcome Measures

    Area Under the Concentration-Time Curve(AUC 0 through the end of study )

    Trial Keywords

    KTN0158

    Advanced Cancer

    Phase 1

    Monoclonal Antibody

    Safety and Pharmacokinetics