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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02281409
• Collaborator: Kyowa Hakko Kirin Pharma, Inc. (Industry)
• Enrollment: 17
• Location: 1
• Arms: 2
• Duration (Months): 64
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential 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: Oct 1, 2014
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

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.	Biological: Mogamulizumab (KW-0761)
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).	Biological: Mogamulizumab (KW-0761)

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 17, 2016

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT02281409
• Other Study ID Numbers: 14-135
• First Posted: Nov 2, 2014
• Last Update Posted: Apr 23, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Memorial Sloan Kettering Cancer Center: Mogamulizumab (KW-0761); 14-135
• Additional relevant MeSH terms: Neoplasms; Mogamulizumab

Study Results

Participant Flow

Arm/Group Title	Cohort 1 (0.5 mg/kg KW-0761 IV)	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Cohort 3 (3.0mg/kg KW-0761IV)	Cohort 4 (10.0mg/kg KW-0761IV)
Arm/Group Description	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). 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). 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). 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). Mogamulizumab (KW-0761)
Period Title: Overall Study
STARTED	3	3	5	6
COMPLETED	3	3	5	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1 (0.5 mg/kg KW-0761 IV)	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Cohort 3 (3.0mg/kg KW-0761IV)	Cohort 4 (10.0mg/kg KW-0761IV)	Total
Arm/Group Description	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). 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). 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). 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). Mogamulizumab (KW-0761)	Total of all reporting groups
Overall Participants	3	3	5	6	17
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.3	58.3	57	58.7	58.7
Sex: Female, Male (Count of Participants)
Female	0 0%	2 66.7%	1 20%	3 50%	6 35.3%
Male	3 100%	1 33.3%	4 80%	3 50%	11 64.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 100%	3 100%	5 100%	5 83.3%	16 94.1%
Not Hispanic or Latino	0 0%	0 0%	0 0%	1 16.7%	1 5.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	1 20%	0 0%	1 5.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	1 16.7%	1 5.9%
White	3 100%	3 100%	4 80%	4 66.7%	14 82.4%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	1 16.7%	1 5.9%
Region of Enrollment (Count of Participants)
United States	3 100%	3 100%	5 100%	6 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose (MTD)
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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mogamulizumab (KW-0761)
Arm/Group Description	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). Mogamulizumab (KW-0761)
Measure Participants	22
Number [mg/kg KW-0761IV]	10.0

2. Secondary Outcome

Title	Overall Response
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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 (0.5 mg/kg KW-0761 IV)	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Cohort 3 (3.0mg/kg KW-0761IV)	Cohort 4 (10.0mg/kg KW-0761IV)
Arm/Group Description	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). 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). 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). 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). Mogamulizumab (KW-0761)
Measure Participants	3	3	5	6
Progressive disease	1 33.3%	0 0%	4 80%	4 66.7%
Stable disease	2 66.7%	2 66.7%	1 20%	1 16.7%
Not entered	0 0%	1 33.3%	0 0%	1 16.7%

Adverse Events

Time Frame	1 year
Arm/Group Title	Cohort 1 (0.5 mg/kg KW-0761 IV)		Cohort 2 (1.0 mg/kg KW-0761IV) Q2W		Cohort 3 (3.0mg/kg KW-0761IV)		Cohort 4 (10.0mg/kg KW-0761IV)
Arm/Group Description	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). 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). 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). 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). Mogamulizumab (KW-0761)
All Cause Mortality
	Cohort 1 (0.5 mg/kg KW-0761 IV)		Cohort 2 (1.0 mg/kg KW-0761IV) Q2W		Cohort 3 (3.0mg/kg KW-0761IV)		Cohort 4 (10.0mg/kg KW-0761IV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		5/5 (100%)		6/6 (100%)
Serious Adverse Events
	Cohort 1 (0.5 mg/kg KW-0761 IV)		Cohort 2 (1.0 mg/kg KW-0761IV) Q2W		Cohort 3 (3.0mg/kg KW-0761IV)		Cohort 4 (10.0mg/kg KW-0761IV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		2/3 (66.7%)		2/5 (40%)		2/6 (33.3%)
Cardiac disorders
Atrial flutter	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Gastrointestinal disorders
Abdominal pain	0/3 (0%)		0/3 (0%)		0/5 (0%)		2/6 (33.3%)
Constipation	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Gastrointestinal disorders - Other, specify	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Rectal pain	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
General disorders
Non-cardiac chest pain	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Infections and infestations
Lung infection	2/3 (66.7%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Nervous system disorders
Nervous system disorders - Other, specify	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Pleural effusion	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Pleural hemorrhage	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1 (0.5 mg/kg KW-0761 IV)		Cohort 2 (1.0 mg/kg KW-0761IV) Q2W		Cohort 3 (3.0mg/kg KW-0761IV)		Cohort 4 (10.0mg/kg KW-0761IV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		5/5 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Anemia	3/3 (100%)		2/3 (66.7%)		4/5 (80%)		3/6 (50%)
Gastrointestinal disorders
Constipation	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)
Abdominal Pain	0/3 (0%)		0/3 (0%)		2/5 (40%)		2/6 (33.3%)
Nausea	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Rectal pain	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Vomiting	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
General disorders
Fatigue	3/3 (100%)		1/3 (33.3%)		1/5 (20%)		0/6 (0%)
Fever	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Pain	0/3 (0%)		2/3 (66.7%)		1/5 (20%)		1/6 (16.7%)
Infections and infestations
Lung infection	2/3 (66.7%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Nail infection	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Skin infection	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Upper respiratory infection	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Urinary tract infection	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/3 (0%)		0/3 (0%)		0/5 (0%)		2/6 (33.3%)
Investigations
Lymphocyte count decreased	3/3 (100%)		3/3 (100%)		3/5 (60%)		5/6 (83.3%)
Alanine aminotransferase increased	1/3 (33.3%)		0/3 (0%)		1/5 (20%)		2/6 (33.3%)
Platelet count decreased	1/3 (33.3%)		1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)
White blood cell decreased	1/3 (33.3%)		2/3 (66.7%)		0/5 (0%)		3/6 (50%)
Alkaline phosphatase increased	1/3 (33.3%)		0/3 (0%)		3/5 (60%)		3/6 (50%)
Blood bilirubin increased	1/3 (33.3%)		0/3 (0%)		3/5 (60%)		2/6 (33.3%)
Neutrophil count decreased	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)
Activated partial thromboplastin time prolonged	0/3 (0%)		0/3 (0%)		3/5 (60%)		2/6 (33.3%)
Aspartate aminotransferase increased	1/3 (33.3%)		1/3 (33.3%)		2/5 (40%)		3/6 (50%)
Creatinine increased	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Fibrinogen decreased	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
INR increased	1/3 (33.3%)		0/3 (0%)		1/5 (20%)		2/6 (33.3%)
Lipase increased	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Serum amylase increased	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Metabolism and nutrition disorders
Hyperglycemia	2/3 (66.7%)		1/3 (33.3%)		2/5 (40%)		4/6 (66.7%)
Hypoalbuminemia	2/3 (66.7%)		1/3 (33.3%)		4/5 (80%)		4/6 (66.7%)
Hypercalcemia	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Hyperkalemia	0/3 (0%)		0/3 (0%)		0/5 (0%)		2/6 (33.3%)
Hypocalcemia	2/3 (66.7%)		1/3 (33.3%)		2/5 (40%)		3/6 (50%)
Hypoglycemia	0/3 (0%)		0/3 (0%)		1/5 (20%)		1/6 (16.7%)
Hypokalemia	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)
Hypomagnesemia	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Hyponatremia	1/3 (33.3%)		1/3 (33.3%)		1/5 (20%)		1/6 (16.7%)
Hypophosphatemia	1/3 (33.3%)		2/3 (66.7%)		2/5 (40%)		2/6 (33.3%)
Musculoskeletal and connective tissue disorders
Back pain	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Psychiatric disorders
Depression	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Dyspnea	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Hiccups	0/3 (0%)		0/3 (0%)		1/5 (20%)		0/6 (0%)
Hypoxia	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Pleural hemorrhage	1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)
Skin & subcutaneous tissue disorders	0/3 (0%)		0/3 (0%)		0/5 (0%)		1/6 (16.7%)
Dry skin	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)
Vascular disorders
Hypertension	0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.