Trial Outcomes & Findings for PTX-35 in Patients With Advanced Solid Tumors (NCT NCT04430348)
NCT ID: NCT04430348
Last Updated: 2024-03-12
Results Overview
TEAEs during the trial
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
PTX-35 Dose Level 1
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
PTX-35 Dose Level 1
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
2
|
2
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
2
|
0
|
1
|
1
|
Baseline Characteristics
PTX-35 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
PTX-35 Dose Level 1
n=3 Participants
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
n=3 Participants
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
n=4 Participants
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
n=3 Participants
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
n=3 Participants
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
n=6 Participants
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=93 Participants
|
68 years
n=4 Participants
|
54 years
n=27 Participants
|
76 years
n=483 Participants
|
61 years
n=36 Participants
|
60 years
n=10 Participants
|
67.5 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
3 participants
n=483 Participants
|
3 participants
n=36 Participants
|
6 participants
n=10 Participants
|
22 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsTEAEs during the trial
Outcome measures
| Measure |
PTX-35 Dose Level 1
n=3 Participants
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
n=3 Participants
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
n=4 Participants
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
n=3 Participants
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
n=3 Participants
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
n=6 Participants
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
|---|---|---|---|---|---|---|
|
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
PTX-35 Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
PTX-35 Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
PTX-35 Dose Level 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
PTX-35 Dose Level 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
PTX-35 Dose Level 5
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
PTX-35 Dose Level 6
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
PTX-35 Dose Level 1
n=3 participants at risk
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
n=3 participants at risk
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
n=4 participants at risk
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
n=3 participants at risk
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
n=3 participants at risk
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
n=6 participants at risk
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
Other adverse events
| Measure |
PTX-35 Dose Level 1
n=3 participants at risk
Dose Level 1: PTX-35 0.01 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 2
n=3 participants at risk
Dose Level 2: PTX-35 0.03 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 3
n=4 participants at risk
Dose Level 3: PTX-35 0.10 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 4
n=3 participants at risk
Dose Level 4: PTX-35 0.30 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 5
n=3 participants at risk
Dose Level 5: PTX-35 1.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
PTX-35 Dose Level 6
n=6 participants at risk
Dose Level 6: PTX-35 3.0 mg/kg
PTX-35: Monoclonal antibody PTX-35
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
50.0%
2/4 • Number of events 2 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
66.7%
2/3 • Number of events 2 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
2/6 • Number of events 2 • At least 12 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
100.0%
3/3 • Number of events 3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
2/6 • Number of events 2 • At least 12 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
General disorders
Chills
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
66.7%
2/3 • Number of events 2 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
2/6 • Number of events 2 • At least 12 months
|
|
Skin and subcutaneous tissue disorders
Cholestatic pruritus
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
16.7%
1/6 • Number of events 1 • At least 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
25.0%
1/4 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/3 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
0.00%
0/4 • At least 12 months
|
0.00%
0/3 • At least 12 months
|
33.3%
1/3 • Number of events 1 • At least 12 months
|
0.00%
0/6 • At least 12 months
|
Additional Information
Vice President, Clinical Development
NightHawk Biosciences Inc.
Phone: 9197948950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement, Non-disclosure and Clinical Trial Agreement
- Publication restrictions are in place
Restriction type: OTHER