Trial Outcomes & Findings for A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients (NCT NCT01308762)

NCT ID: NCT01308762

Last Updated: 2012-12-06

Results Overview

Safety and tolerability were measured with respect to: 1. Safety measurements 2. Local tolerability at the site of intradermal injection 3. Incidence of adverse events.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 19 participants
• Primary outcome timeframe: 56 days
• Results posted on: 2012-12-06

Participant Flow

A total of 24 patients with melanoma entered the screening phase of this study between 10 March 2010 and 27 July 2010.

Five patients were found to be ineligible and failed screening. These patients were withdrawn before receiving study medication.

Participant milestones

Measure	IMM-101 1.0 mg Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.	IMM-101 0.1 mg Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.	IMM-101 0.5 mg Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
Overall Study STARTED	6	6	7
Overall Study COMPLETED	6	6	6
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	IMM-101 1.0 mg Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.	IMM-101 0.1 mg Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.	IMM-101 0.5 mg Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

Baseline characteristics by cohort

Measure	Group 1 n=6 Participants IMM-101 0.1 mg	Group 2 n=7 Participants IMM-101 0.5 mg	Group 3 n=6 Participants IMM-101 1.0 mg	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Age Continuous	47.3 years STANDARD_DEVIATION 17.3 • n=5 Participants	56.1 years STANDARD_DEVIATION 20.2 • n=7 Participants	56.3 years STANDARD_DEVIATION 18.8 • n=5 Participants	53.4 years STANDARD_DEVIATION 18.3 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	19 participants n=4 Participants

PRIMARY outcome

Timeframe: 56 days

Population: All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population

Safety and tolerability were measured with respect to:

1. Safety measurements

2. Local tolerability at the site of intradermal injection

3. Incidence of adverse events.

Outcome measures

Measure	IMM-101 0.1 mg n=6 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).	IMM-101 0.5 mg n=7 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).	IMM-101 1.0 mg n=6 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	6 Participants	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Day -3 to Day 56

Population: Safety population

Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.

Outcome measures

Measure	IMM-101 0.1 mg n=6 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).	IMM-101 0.5 mg n=7 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).	IMM-101 1.0 mg n=6 Participants IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
Administration Site Reactions	1 Participants	3 Participants	5 Participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=6 participants at risk IMM-101 0.1 mg	Group 2 n=7 participants at risk IMM-101 0.5 mg	Group 3 n=6 participants at risk IMM-101 1.0 mg
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.

Other adverse events

Measure	Group 1 n=6 participants at risk IMM-101 0.1 mg	Group 2 n=7 participants at risk IMM-101 0.5 mg	Group 3 n=6 participants at risk IMM-101 1.0 mg
Cardiac disorders Altered ECG	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Infections and infestations Chest Infection	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Infections and infestations Common cold	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	28.6% 2/7 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enlarged Lymph node	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Eye disorders Eye proptosis	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Flu-like symptoms	33.3% 2/6 • Number of events 2 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	28.6% 2/7 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	33.3% 2/6 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Generalised or joint ache /pain	50.0% 3/6 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	57.1% 4/7 • Number of events 11 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	83.3% 5/6 • Number of events 11 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Hard red swelling on cheek	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	66.7% 4/6 • Number of events 8 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Infections and infestations Herpes	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Hypotension	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	28.6% 2/7 • Number of events 2 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Investigations Increased LDH	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Injection site reaction	16.7% 1/6 • Number of events 5 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	42.9% 3/7 • Number of events 5 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	83.3% 5/6 • Number of events 19 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Ear and labyrinth disorders Mild ear pain	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New Lump	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New lesion	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 2 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Cardiac disorders Palpitations	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Eye disorders Red eye	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Redness on face	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Skin and subcutaneous tissue disorders Skin erythema	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Gastrointestinal disorders Sore throat	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	28.6% 2/7 • Number of events 2 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Temperature	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	28.6% 2/7 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	33.3% 2/6 • Number of events 3 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Tiredness	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	14.3% 1/7 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
Infections and infestations Warts	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
General disorders Malaise	0.00% 0/6 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	0.00% 0/7 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.	16.7% 1/6 • Number of events 1 • Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56 In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.

Additional Information

Clinical Trials Co-ordinator

Immodulon Therapeutics, The London Clinic Cancer Centre, London W1G 6JA,

Phone: +44 (0)203 219 3568/3572

Email: Ilda@immodulon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60