Trial Outcomes & Findings for A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer (NCT NCT01539824)
NCT ID: NCT01539824
Last Updated: 2024-11-25
Results Overview
The disease stabilisation rate at 24 weeks defined as the proportion of patients with a complete response, partial response or stable disease in accordance with immune-related response criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
IMM-101 Plus Stereotactic Body Radiation Therapy (SBRT)
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer
Baseline characteristics by cohort
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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5 Participants
n=5 Participants
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Age, Categorical
>=65 years
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7 Participants
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 weeksThe disease stabilisation rate at 24 weeks defined as the proportion of patients with a complete response, partial response or stable disease in accordance with immune-related response criteria.
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Disease Stabilisation Rate
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0 Participants
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SECONDARY outcome
Timeframe: 48 weeksPopulation: All enrolled patients
Safety and tolerability profiles as judged by: Local and systemic toxicities. Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. Safety and tolerability are be monitored through the study by a Data Monitoring Committee (DMC)
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Safety and Tolerability Profiles
Adverse events (AE) reported
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156 Adverse event
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Safety and Tolerability Profiles
Serious adverse events (SAE) reported
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0 Adverse event
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SECONDARY outcome
Timeframe: 12, 24, 36 and 48 weeksPopulation: All enrolled patients who were still in follow up at each timepoint
Patients with an objective response were those who had a complete (CR) or partial response (PR), or stable disease(SD) based on CT scan findings, absence of clinical signs and symptoms of progression, did not withdraw due to disease progression prior to/at the Week 12/ 24 /36 / 48 assessment and were alive at the relevant assessment point
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Objective Response Rate
Number of patients with objective response at Week 36
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0 Participants
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Objective Response Rate
Number of patients with objective response at Week 48
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0 Participants
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Objective Response Rate
Number of patients with objective response at Week 12
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0 Participants
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Objective Response Rate
Number of patients with objective response at Week 24
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0 Participants
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SECONDARY outcome
Timeframe: 12, 36 and 48 weeksPatients with disease stabilisation were those who had CR, PR, or SD based on CT scan findings, absence of clinical signs and symptoms of progression, did not withdraw due to disease progression prior to/at the Week 24, 36 or 48 assessment and were alive at the respective assessment.
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Disease Stabilisation Rate
Number of patients with disease stabilisation at Week 36
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0 Participants
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Disease Stabilisation Rate
Number of patients with disease stabilisation at Week 12
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0 Participants
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Disease Stabilisation Rate
Number of patients with disease stabilisation at Week 48
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0 Participants
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SECONDARY outcome
Timeframe: 12, 36 and 48 weeks.The overall disease stabilisation rate was recorded as the percentage of patients with a CR, PR or SD as best overall response and was to be assessed at 12, 24 (primary time point), 36 and 48 weeks and overall.
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Overall Disease Stabilisation Rate
Overall disease stabilisation rate at Week 12
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0 Participants
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Overall Disease Stabilisation Rate
Overall disease stabilisation rate at Week 36
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0 Participants
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Overall Disease Stabilisation Rate
Overall disease stabilisation rate at Week 48
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0 Participants
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SECONDARY outcome
Timeframe: 12, 24, 36 and 48 weeks.The overall response rate will be recorded as the percentage of patients with a CR or PR as best overall response.
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Overall Response Rate
Overall response rate at Week 48
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0 Participants
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Overall Response Rate
Overall response rate at Week 12
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0 Participants
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Overall Response Rate
Overall response rate at Week 24
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0 Participants
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Overall Response Rate
Overall response rate at Week 36
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0 Participants
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SECONDARY outcome
Timeframe: 12, 24, 36 and 48 weeksPopulation: One patient died during the study due to the AE of Jaundice (unrelated to IMM-101). The remaining 11 patients died after withdrawal from the study.
The number of patients alive at 12, 24, 36 \& 48 weeks. Patients without a date of death were to be censored at the date the patient was last known to be alive. The protocol made provision for patients to continue to be followed up and data to be collected, post study withdrawal.
Outcome measures
| Measure |
IMM-101 Plus SBRT
n=12 Participants
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Mycobacterium obuense: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
SBRT: The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
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Survival
Number of patients alive at 12 weeks
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10 Participants
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Survival
Number of patients alive at 24 weeks
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6 Participants
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Survival
Number of patients alive at 36 weeks
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3 Participants
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Survival
Number of patients alive at 48 weeks
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2 Participants
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Adverse Events
Overall Study Population
Serious events: 0 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study Population
n=12 participants at risk
All enrolled patients were included in the analysis population
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General disorders
Fatigue
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58.3%
7/12 • Number of events 9 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Injection site reaction
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33.3%
4/12 • Number of events 13 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Peripheral odeama
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16.7%
2/12 • Number of events 5 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Chest pain
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8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Chills
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8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Influenza like symptoms
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8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Night sweats
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8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Pain
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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General disorders
Temperature intolerance
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8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Blood lactate dehydrogenase increased
|
41.7%
5/12 • Number of events 5 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Blood bilirubin increased
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25.0%
3/12 • Number of events 3 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Gamma glutamyltransferase increased
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25.0%
3/12 • Number of events 3 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Weight decreased
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25.0%
3/12 • Number of events 3 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
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Investigations
Blood alkaline phosphatase increased
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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|
General disorders
RBC sedimentation rateincreased
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
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Investigations
Blood urine present
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
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Investigations
C-reactive protein increased
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
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Investigations
Carcinoembryonic antgen increased
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Investigations
Hemoglobin increased
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
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Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
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Investigations
Urine ketone body present
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • Number of events 6 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
4/12 • Number of events 6 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
3/12 • Number of events 3 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Umbilical hernia
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.7%
5/12 • Number of events 5 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Metabolism and nutrition disorders
Cachexia
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • Number of events 8 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal psin
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Nervous system disorders
Depressed level of consciousness
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Nervous system disorders
Lethargy
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Nervous system disorders
SCiatica
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Hepatobiliary disorders
Jaundice
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Hepatobiliary disorders
Hepatic pain
|
8.3%
1/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Hepatobiliary disorders
Hepatomegaly
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 2 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Vascular disorders
Vena cava thrombosis
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Cardiac disorders
Cardiac insufficiency
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Cardiac disorders
Sinus tachtcardia
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
2/12 • Number of events 3 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • From screening until end of study (up to 54 weeks)
It was the responsibility of the investigator to report any directly observed AEs and AEs reported spontaneously by the patient, throughout the study after patient consent, and for IMM-101-related AEs, up to 30 days after the last study visit.
|
Additional Information
Chief Medical Officer
Immodulon Therapeutics Ltd
Phone: +44 (0)20 3137 6346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place