Clinical Trials /

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



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:



Phase 1/Phase 2

Trial Eligibility



  • 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

  • ORG STUDY ID: 14-135
  • NCT ID: NCT02281409


  • Advanced Solid Tumors
  • Metastatic Solid Tumors


Mogamulizumab (KW-0761)Phase I: Mogamulizumab (KW-0761)


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.

Trial Arms

Phase I: Mogamulizumab (KW-0761)ExperimentalPatients 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.
  • Mogamulizumab (KW-0761)
Phase II: Mogamulizumab (KW-0761)ExperimentalPhase 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).
  • Mogamulizumab (KW-0761)

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

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

          -  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

               -  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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD)
Time Frame:1 year
Safety Issue:
Description: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

Measure:Overall Response
Time Frame:2 years
Safety Issue:
Description:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Mogamulizumab (KW-0761)
  • 14-135

Last Updated

April 23, 2021