- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281409
Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
March 30, 2021 updated by: Memorial Sloan Kettering Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase I: 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.
|
|
Experimental: Phase II: Mogamulizumab (KW-0761)
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jedd Wolchok, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
October 29, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimate)
November 2, 2014
Study Record Updates
Last Update Posted (Actual)
April 23, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumors
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States, Australia
-
Alphamab (Australia) Co Pty Ltd.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsAustralia
Clinical Trials on Mogamulizumab (KW-0761)
-
PfizerKyowa Kirin Co., Ltd.TerminatedAdvanced/Metastatic Solid TumorsUnited States
-
Kyowa Hakko Kirin Pharma, Inc.CompletedPeripheral T-Cell LymphomaFrance, United Kingdom, Netherlands, Denmark, Italy, Spain
-
Aichi Medical UniversityUnknown
-
Kyowa Kirin, Inc.CompletedCarcinoma | Cancer | Solid TumorUnited States, France
-
Kyowa Kirin Co., Ltd.CompletedPeripheral T/NK-cell LymphomaJapan
-
Kyowa Hakko Kirin Pharma, Inc.CompletedPeripheral T-Cell LymphomaUnited States
-
Kyowa Hakko Kirin Pharma, Inc.CompletedCutaneous T-cell Lymphoma | Peripheral T-cell LymphomaUnited States
-
Kyowa Kirin Co., Ltd.CompletedAdult T-cell Leukemia-lymphomaJapan
-
Kyowa Kirin Co., Ltd.CompletedAdult T-Cell Leukemia and Lymphoma (ATL) | Adult Peripheral T-Cell Lymphoma (PTCL)Japan
-
Kyowa Kirin Co., Ltd.TerminatedHTLV-1 Associated MyelopathyJapan