Trial Outcomes & Findings for Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (NCT NCT02310464)
NCT ID: NCT02310464
Last Updated: 2022-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort
Results posted on
2022-10-03
Participant Flow
Participant milestones
| Measure |
Dose Escalation - Cohort 1
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects in the dose escalation phase were not screened for Globo H expression. Only subjects in the cohort expansion phase were screened for Globo H expression for enrollment.
Baseline characteristics by cohort
| Measure |
Dose Escalation - Cohort 1
n=4 Participants
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
n=3 Participants
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
n=4 Participants
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
n=14 Participants
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=14 Participants
|
17 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=14 Participants
|
8 Participants
n=25 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10.61 • n=4 Participants
|
65 years
STANDARD_DEVIATION 10.44 • n=3 Participants
|
58 years
STANDARD_DEVIATION 9.42 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 10.25 • n=14 Participants
|
60.3 years
STANDARD_DEVIATION 9.82 • n=25 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=14 Participants
|
16 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=14 Participants
|
9 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=14 Participants
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=14 Participants
|
16 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
7 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=4 Participants
|
3 participants
n=3 Participants
|
3 participants
n=4 Participants
|
0 participants
n=14 Participants
|
9 participants
n=25 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=4 Participants
|
0 participants
n=3 Participants
|
1 participants
n=4 Participants
|
14 participants
n=14 Participants
|
16 participants
n=25 Participants
|
|
Cancer Type
Colorectal
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
8 Participants
n=25 Participants
|
|
Cancer Type
Lung
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=25 Participants
|
|
Cancer Type
Breast
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=25 Participants
|
|
Tumor Globo H Expression
|
—
|
—
|
—
|
130.6 scores on a scale
STANDARD_DEVIATION 83.77 • n=14 Participants • Subjects in the dose escalation phase were not screened for Globo H expression. Only subjects in the cohort expansion phase were screened for Globo H expression for enrollment.
|
130.6 scores on a scale
STANDARD_DEVIATION 83.77 • n=14 Participants • Subjects in the dose escalation phase were not screened for Globo H expression. Only subjects in the cohort expansion phase were screened for Globo H expression for enrollment.
|
PRIMARY outcome
Timeframe: Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohortOutcome measures
| Measure |
Dose Escalation - Cohort 1
n=4 Participants
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
n=3 Participants
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
n=4 Participants
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
n=14 Participants
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any TEAEs
|
4 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious TEAEs
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohortAnti-Globo H IgM and IgG concentrations were measured using a chemical binding assay.
Outcome measures
| Measure |
Dose Escalation - Cohort 1
n=4 Participants
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
n=3 Participants
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
n=4 Participants
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
n=14 Participants
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
|---|---|---|---|---|
|
Maximal Post-baseline Anti-Globo H Antibody Responses
Maximal post-baseline anti-Globo H IgM concentration
|
4.602 μg/mL
Interval 0.392 to 54.081
|
2.048 μg/mL
Interval 1.116 to 3.758
|
3.165 μg/mL
Interval 2.322 to 4.315
|
13.920 μg/mL
Interval 5.835 to 33.207
|
|
Maximal Post-baseline Anti-Globo H Antibody Responses
Maximal post-baseline anti-Globo H IgG concentration
|
5.011 μg/mL
Interval 0.209 to 120.156
|
1.000 μg/mL
All three subjects had the same maximal IgG concentration, i.e. no variation. Therefore, the CI (calculated using the variance) cannot be calculated, i.e. not available.
|
2.186 μg/mL
Interval 0.406 to 11.783
|
9.472 μg/mL
Interval 4.372 to 20.523
|
Adverse Events
Dose Escalation - Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation - Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation - Cohort 3
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Expansion Cohort
Serious events: 3 serious events
Other events: 13 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Escalation - Cohort 1
n=4 participants at risk
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
n=3 participants at risk
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
n=4 participants at risk
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
n=14 participants at risk
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
|---|---|---|---|---|
|
General disorders
Disease Progression
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
Other adverse events
| Measure |
Dose Escalation - Cohort 1
n=4 participants at risk
10 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 2
n=3 participants at risk
30 μg OBI-833/100 μg OBI-821
|
Dose Escalation - Cohort 3
n=4 participants at risk
100 μg OBI-833/100 μg OBI-821
|
Expansion Cohort
n=14 participants at risk
NSCLC patients receiving 30 μg OBI-833/100 μg OBI-821
|
|---|---|---|---|---|
|
General disorders
Injection site induration
|
75.0%
3/4 • Number of events 7 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
100.0%
3/3 • Number of events 8 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 5 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site erythema
|
50.0%
2/4 • Number of events 10 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
100.0%
3/3 • Number of events 14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site pain
|
25.0%
1/4 • Number of events 6 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
100.0%
3/3 • Number of events 17 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 12 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site pruritus
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 6 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site swelling
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
66.7%
2/3 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 6 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
7/14 • Number of events 35 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
66.7%
2/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
66.7%
2/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
66.7%
2/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
50.0%
2/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
28.6%
4/14 • Number of events 4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
66.7%
2/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
50.0%
2/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
RBC sedimentation rate increased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
14.3%
2/14 • Number of events 3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Device occlusion
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Early satiety
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site oedema
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site rash
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Injection site warmth
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Paronychia
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
33.3%
1/3 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Nervous system disorders
Burning sensations
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 2 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Eye disorders
Conjunctivaloedema
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Psychiatric disorders
Irritability
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Psychiatric disorders
Nervousness
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
25.0%
1/4 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/14 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 5 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/3 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
0.00%
0/4 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
7.1%
1/14 • Number of events 1 • Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place