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

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ClinicalTrials.gov Identifier: NCT02281409
Recruitment Status : Recruiting
First Posted : November 3, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Kyowa Hakko Kirin Pharma, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Metastatic Solid Tumors Biological: Mogamulizumab (KW-0761) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Mogamulizumab (KW-0761)
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 end of treatment or treatment completion date, 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).
Biological: Mogamulizumab (KW-0761)



Primary Outcome Measures :
  1. maximum tolerated dose (MTD) [ Time Frame: 1 year ]
    A standard 3+3 design will be utilized to determine the MTD. Four dose levels of KW-0761 will be investigated (0.5mg/kg, 1mg/kg, 3mg/kg, 10mg/kg). Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.


Secondary Outcome Measures :
  1. Overall response [ Time Frame: 2 years ]
    using both RECIST v1.1 and immune-related response criteria (irRC) in cohorts of three specific tumor types treated at the MTD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (T -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/μl
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281409


Contacts
Contact: Jedd Wolchok, MD, PhD 646-888-2395
Contact: George Plitas, MD 646-888-4587

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jedd Wolchok, MD, PhD    646-888-2395      
Contact: George Plitas, MD    646-888-4587      
Principal Investigator: Jedd Wolchok, MD, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Principal Investigator: Jedd Wolchok, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02281409     History of Changes
Other Study ID Numbers: 14-135
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Mogamulizumab (KW-0761)
14-135

Additional relevant MeSH terms:
Neoplasms