Trial Outcomes & Findings for Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors (NCT NCT02281409)
NCT ID: NCT02281409
Last Updated: 2021-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
1 year
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
Cohort 1 (0.5 mg/kg KW-0761 IV)
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1 (0.5 mg/kg KW-0761 IV)
n=3 Participants
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
n=3 Participants
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
n=5 Participants
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
n=6 Participants
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
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
n=5 Participants
|
58.3 years
n=7 Participants
|
57 years
n=5 Participants
|
58.7 years
n=4 Participants
|
58.7 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearA 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.
Outcome measures
| Measure |
Mogamulizumab (KW-0761)
n=22 Participants
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
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)
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
10.0 mg/kg KW-0761IV
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPer 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.
Outcome measures
| Measure |
Mogamulizumab (KW-0761)
n=3 Participants
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
n=3 Participants
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
n=5 Participants
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
n=6 Participants
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)
|
|---|---|---|---|---|
|
Overall Response
Not entered
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overall Response
Progressive disease
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Overall Response
Stable disease
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort 1 (0.5 mg/kg KW-0761 IV)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3 (3.0mg/kg KW-0761IV)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Cohort 4 (10.0mg/kg KW-0761IV)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort 1 (0.5 mg/kg KW-0761 IV)
n=3 participants at risk
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
n=3 participants at risk
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
n=5 participants at risk
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
n=6 participants at risk
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)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Lung infection
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
Other adverse events
| Measure |
Cohort 1 (0.5 mg/kg KW-0761 IV)
n=3 participants at risk
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)
|
Cohort 2 (1.0 mg/kg KW-0761IV) Q2W
n=3 participants at risk
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)
|
Cohort 3 (3.0mg/kg KW-0761IV)
n=5 participants at risk
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)
|
Cohort 4 (10.0mg/kg KW-0761IV)
n=6 participants at risk
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)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • 1 year
|
66.7%
2/3 • 1 year
|
80.0%
4/5 • 1 year
|
50.0%
3/6 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • 1 year
|
100.0%
3/3 • 1 year
|
60.0%
3/5 • 1 year
|
83.3%
5/6 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/5 • 1 year
|
50.0%
3/6 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
60.0%
3/5 • 1 year
|
50.0%
3/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
40.0%
2/5 • 1 year
|
66.7%
4/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
60.0%
3/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
General disorders
Fatigue
|
100.0%
3/3 • 1 year
|
33.3%
1/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
80.0%
4/5 • 1 year
|
66.7%
4/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
40.0%
2/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
60.0%
3/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
40.0%
2/5 • 1 year
|
50.0%
3/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Fever
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
40.0%
2/5 • 1 year
|
50.0%
3/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
20.0%
1/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • 1 year
|
66.7%
2/3 • 1 year
|
40.0%
2/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Investigations
INR increased
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
33.3%
2/6 • 1 year
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Lung infection
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Pain
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • 1 year
|
20.0%
1/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/5 • 1 year
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/6 • 1 year
|
Additional Information
Dr. Jedd Wolchok, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-2315
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place