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

Advanced Solid Tumors Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02281409
• Other study ID #: 14-135
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2014
• Est. completion date: February 2020

Study information

• Verified date: December 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Biological:
• Mogamulizumab (KW-0761)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	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	Overall Response	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

External Links

•   Memorial Sloan Kettering Cancer Center