Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02281409|
Recruitment Status : Recruiting
First Posted : November 3, 2014
Last Update Posted : September 6, 2017
|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)|
|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|
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)|
- 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.
- 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.
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
|Contact: Jedd Wolchok, MD, PhD||646-888-2395|
|Contact: George Plitas, MD||646-888-4587|
|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|
|Principal Investigator:||Jedd Wolchok, MD, PhD||Memorial Sloan Kettering Cancer Center|