Clinical Trials /

Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors

NCT02281409

Description:

The purpose of this study is to find out what effects, good and/or bad, KW-0761, an investigational drug, has on the patient and their cancer.

Related Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (<span class="go-doc-concept go-doc-intervention">KW-0761</span>) in Subjects With Advanced and/or Metastatic Solid Tumors

Title

  • Brief Title: Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
  • Official Title: A Phase I/II Study of the Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02281409

    ORG ID: 14-135

    Trial Conditions

    Advanced Solid Tumors

    Metastatic Solid Tumors

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    The purpose of this study is to find out what effects, good and/or bad, KW-0761, an
    investigational drug, has on the patient and their cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Mogamulizumab (KW-0761) Experimental Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following the last dose, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).

    Eligibility Criteria

    Inclusion Criteria:

    - Informed Consent form signed by the subject.

    - Males and females 18 years or older at the time of dose initiation.

    - Histologically confirmed unresectable solid tumor malignancy with at least 1
    measurable lesion. In the expansion phase, eligibility will be limited to metastatic
    triple negative breast cancer that has received prior taxane and anthracycline
    therapy; Metastatic NSCLC that is not ALK+ and does not have a EGFR sensitizing
    mutation; and metastatic gastric cancer

    - Previously treated for an advanced cancer and there are no curative therapy options
    available

    - Karnofsky Performance Status 70 in the 30 day baseline period immediately prior to
    dosing.

    - Evidence of adequate organ function by standard laboratory tests:

    - Serum creatinine (Cr) 1.5 X upper limit of normal (ULN)

    - Serum total and direct bilirubin (T -Bil or D-Bil)) 1.5 X ULN (prior diagnosis
    or past history consistent with Gilbert's syndrome is an exception)

    - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 X
    ULN

    - Platelets (Plts) 100,000/l

    - Hemoglobin (Hgb) 9.0 g/dL

    - Absolute neutrophil count (ANC) 1000/mm3

    - All female subjects of childbearing age must be either surgically sterile,
    postmenopausal for at least 1 year, or using an acceptable method of contraception.
    Examples of adequate methods of contraception include abstinence, intrauterine
    device, hormonal contraception, use of spermicide and a condom by sexual partner, or
    partner with a vasectomy. Adequate contraception must be used from the beginning of
    the screening period until at least 16 weeks after the last dose of KW-0761. Male
    subjects with partners of childbearing potential must use a barrier method of
    contraception from the day of the first dose of KW-0761 until at least 16 weeks after
    the last dose.

    - Life expectancy > 12 weeks

    - Previously treated for advanced cancer with no additional therapy options available
    known to prolong survival.

    Exclusion Criteria:

    - Evidence of clinically significant of central nervous system (CNS) metastases or
    symptomatic CNS metastases within 30 days prior to dosing.

    History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis.

    - A history of any major surgery within 6 weeks prior to dosing.

    - Any history of systemic anticancer therapy (standard or experimental) completed
    within 30 days prior to dosing, with the exception of palliative ablation of
    lesion(s) as long as measurable disease lesion(s) remain for evaluation of
    exploratory endpoints.

    - Any concomitant serious physical illness other than cancer (i.e., immune deficiency
    disease, bleeding disorder, etc.) within 1 year prior to dosing.

    - Any history of Stevens-Johnson syndrome.

    - Clinically significant heart disease, defined as NYHA Class III or IV.

    - Any allergic reaction to a previously administered monoclonal antibody or other
    therapeutic protein.

    - Any significant systemic infection within 4 weeks prior to dosing.

    - Pregnancy or breast-feeding.

    - An existing diagnosis of HIV, hepatitis B, hepatitis C, or any current laboratory
    findings or clinical signs and symptoms that suggest these conditions.

    - Subjects with active herpes simplex or herpes zoster. Subjects with a history of
    herpes zoster who have had an outbreak within the last year will also be excluded.
    Subjects on prophylaxis for herpes who started taking medication at least 30 days
    prior to study entry, should continue to take the prescribed medication for the
    duration of the study.

    - Unresolved immune- related adverse events following prior biological therapy

    - Use of any investigational drugs within 30 days prior to dosing.

    - Any condition that requires or is likely to require treatment with systemic
    corticosteroids within the Core Study Period and short term follow-up.

    - Subjects that have had a myocardial infarction within the last 6 months.

    - Subjects on any immunomodulatory drug.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    maximum tolerated dose (MTD)

    Secondary Outcome Measures

    Overall response

    Trial Keywords

    Mogamulizumab (KW-0761)

    14-135