Trial Outcomes & Findings for Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer (NCT NCT03937141)
NCT ID: NCT03937141
Last Updated: 2022-01-03
Results Overview
To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 25 months
Results posted on
2022-01-03
Participant Flow
Participants were enrolled from 17 study centers in the United States.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
ADU-S100 and Pembrolizumab
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
ADU-S100: intratumoral
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
ADU-S100 and Pembrolizumab
n=16 Participants
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
ADU-S100: intratumoral
|
|---|---|
|
Age, Customized
< 65
|
12 Participants
n=5 Participants
|
|
Age, Customized
>= 65
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 25 monthsPopulation: Analysis performed on subjects who had ≥ 1 post-baseline response assessment.
To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Outcome measures
| Measure |
ADU-S100 and Pembrolizumab
n=6 Participants
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
ADU-S100: intratumoral
|
|---|---|
|
Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Complete Response
|
1 Participants
|
|
Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Partial Response
|
5 Participants
|
Adverse Events
ADU-S100 and Pembrolizumab
Serious events: 16 serious events
Other events: 16 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ADU-S100 and Pembrolizumab
n=16 participants at risk
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
ADU-S100: intratumoral
|
|---|---|
|
Cardiac disorders
Stress cardiomyopathy
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Endocrine disorders
Hypophysitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Localised oedema
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Immune system disorders
Cytokine release syndrome
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Abscess jaw
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Tooth abscess
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Carotid artery occlusion
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Product Issues
Device malfunction
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
Other adverse events
| Measure |
ADU-S100 and Pembrolizumab
n=16 participants at risk
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
ADU-S100: intratumoral
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
7/16 • Number of events 14 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Aortic valve disease
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Bradycardia
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Stress cardiomyopathy
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Endocrine disorders
Hypophysitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Endocrine disorders
Hypothyroidism
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Eye disorders
Eye inflammation
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Eye disorders
Eye pruritus
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
6/16 • Number of events 9 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
8/16 • Number of events 10 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Dysphagia
|
18.8%
3/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Eructation
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Ileus
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Number of events 11 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • Number of events 7 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Chills
|
31.2%
5/16 • Number of events 8 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Face oedema
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Facial pain
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Fatigue
|
56.2%
9/16 • Number of events 12 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Hypothermia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Influenza like illness
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site discharge
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site pain
|
31.2%
5/16 • Number of events 21 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site scab
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site scar
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site swelling
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Injection site vesicles
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Localised oedema
|
18.8%
3/16 • Number of events 6 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Oedema peripheral
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Pyrexia
|
37.5%
6/16 • Number of events 7 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Secretion discharge
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Immune system disorders
Cytokine release syndrome
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Immune system disorders
Sarcoidosis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Abscess jaw
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Candida infection
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Clostridium difficile infection
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Device related infection
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Otitis media
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Tooth abscess
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
2/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Infections and infestations
Wound infection
|
18.8%
3/16 • Number of events 6 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Blood iron decreased
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
2/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Platelet count increased
|
6.2%
1/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
Weight decreased
|
50.0%
8/16 • Number of events 13 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Investigations
White blood cell count increased
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Decrease appetite
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.8%
3/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
2/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
4/16 • Number of events 8 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Metabolism and nutrition disorders
Malnutrition
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
4/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
18.8%
3/16 • Number of events 5 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
18.8%
3/16 • Number of events 7 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Carotid artery occlusion
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Number of events 5 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Product Issues
Device malfunction
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
General disorders
Complications associated with device
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
12.5%
2/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
4/16 • Number of events 4 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
2/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 3 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Embolism
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 2 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Hypotension
|
31.2%
5/16 • Number of events 6 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Lymphoedema
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
1/16 • Number of events 1 • Subjects were followed for serious and non-serious adverse events (AEs) from Screening until 30 days following the last dose of study drug, up to 1 year, 4 months.
|
Additional Information
Chinook Therapeutics, Inc. (formerly Aduro Biotech, Inc.)
Chinook Therapeutics, Inc.
Phone: 206-485-7051
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restriction - study results first published in a joint multi-center paper unless (a) no multi-center publication, or (b) ≥18 months has passed since completion of the study. Thereafter, Investigator may publish provided that Investigator: (i) provides a copy of the publication to Chinook ≥ 45 days in advance of submission for publication; (ii) deletes Chinook Confidential Information (other than the Study results) and (iii) submission may be delayed up to 90 days to permit IP filings.
- Publication restrictions are in place
Restriction type: OTHER