Trial Outcomes & Findings for Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies (NCT NCT00496860)
NCT ID: NCT00496860
Last Updated: 2013-07-22
Results Overview
Number of serious adverse events per cohort
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
18 months
Results posted on
2013-07-22
Participant Flow
Between 08-2007 and 05-2009, 118 patients were consented and screened, 56 were Human leukocyte antigen (HLA)-A2 positive and had tumor specimens that were positive for target p53 (aa 264-272)/HLA-A\*0201 complex. Thirty HLA-A2-positive patients with p53/HLA-A\*0201 tumors either withdrew consent or did not meet other inclusion/exclusion criteria.
Participant milestones
| Measure |
ALT-801 0.015 mg/kg/Dose
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/ Dose
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
16
|
6
|
|
Overall Study
COMPLETED
|
3
|
15
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
Baseline characteristics by cohort
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
Total
n=26 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
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age Continuous
|
65 years
n=5 Participants
|
51 years
n=7 Participants
|
58 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsNumber of serious adverse events per cohort
Outcome measures
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies
|
0 Events
|
2 Events
|
4 Events
|
PRIMARY outcome
Timeframe: 18 monthsNumber of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
Outcome measures
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
The Maximum-tolerated Dose (MTD) of ALT-801
|
0 events
|
1 events
|
2 events
|
SECONDARY outcome
Timeframe: 24 monthsNumber of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.
Outcome measures
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
Clinical Antitumor Response to ALT-801
|
2 participants
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 24 monthsNumber of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing
Outcome measures
| Measure |
ALT-801 0.015 mg/kg/Dose
n=3 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
ALT-801 Induced Cell-mediated Immune Responses
|
6433 IFNg spots per million PMBCs
Standard Error 2847
|
9117 IFNg spots per million PMBCs
Standard Error 1671
|
1125 IFNg spots per million PMBCs
Standard Error 163
|
SECONDARY outcome
Timeframe: 24 monthsTiter of anti-drug Abs at week 4
Outcome measures
| Measure |
ALT-801 0.015 mg/kg/Dose
n=3 Participants
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 Participants
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 Participants
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
Immunogenicity of ALT-801
|
347 titer
Standard Error 103
|
5483 titer
Standard Error 2310
|
762 titer
Standard Error 97
|
Adverse Events
ALT-801 0.015 mg/kg/Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ALT-801 0.040 mg/kg/Dose
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
ALT-801 0.080 mg/kg/Dose
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 participants at risk
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 participants at risk
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 participants at risk
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Death-NOS
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4
|
0.00%
0/16
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/4
|
0.00%
0/16
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/4
|
0.00%
0/16
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates
|
0.00%
0/4
|
0.00%
0/16
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
ALT-801 0.015 mg/kg/Dose
n=4 participants at risk
0.015 mg/kg/dose of ALT-801
|
ALT-801 0.040 mg/kg/Dose
n=16 participants at risk
0.040 mg/kg/dose of ALT-801
|
ALT-801 0.080 mg/kg/Dose
n=6 participants at risk
0.080 mg/kg/dose of ALT-801
|
|---|---|---|---|
|
Immune system disorders
Rhinitis
|
25.0%
1/4 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
2/4 • Number of events 2
|
75.0%
12/16 • Number of events 12
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4
|
43.8%
7/16 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
75.0%
3/4 • Number of events 3
|
62.5%
10/16 • Number of events 10
|
66.7%
4/6 • Number of events 4
|
|
Cardiac disorders
Supraventricular arrhythmia - Sinus tachycardia
|
0.00%
0/4
|
50.0%
8/16 • Number of events 8
|
50.0%
3/6 • Number of events 3
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
25.0%
1/4 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Hypotension
|
50.0%
2/4 • Number of events 2
|
56.2%
9/16 • Number of events 9
|
83.3%
5/6 • Number of events 5
|
|
Investigations
INR
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2
|
56.2%
9/16 • Number of events 9
|
0.00%
0/6
|
|
General disorders
Fever
|
100.0%
4/4 • Number of events 4
|
100.0%
16/16 • Number of events 16
|
100.0%
6/6 • Number of events 6
|
|
General disorders
Insomnia
|
0.00%
0/4
|
37.5%
6/16 • Number of events 6
|
0.00%
0/6
|
|
General disorders
Rigors/chills
|
50.0%
2/4 • Number of events 2
|
87.5%
14/16 • Number of events 14
|
100.0%
6/6 • Number of events 6
|
|
General disorders
Weight gain
|
50.0%
2/4 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
|
56.2%
9/16 • Number of events 9
|
66.7%
4/6 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
2/4 • Number of events 2
|
50.0%
8/16 • Number of events 8
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1
|
25.0%
4/16 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
37.5%
6/16 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
62.5%
10/16 • Number of events 10
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
62.5%
10/16 • Number of events 10
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC
|
25.0%
1/4 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/4
|
25.0%
4/16 • Number of events 4
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
25.0%
1/4 • Number of events 1
|
37.5%
6/16 • Number of events 6
|
50.0%
3/6 • Number of events 3
|
|
Investigations
ALT
|
25.0%
1/4 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
0.00%
0/6
|
|
Investigations
AST
|
25.0%
1/4 • Number of events 1
|
31.2%
5/16 • Number of events 5
|
0.00%
0/6
|
|
Investigations
Bicarbonate, serum-low
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Bilirubin
|
25.0%
1/4 • Number of events 1
|
25.0%
4/16 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Creatinine
|
0.00%
0/4
|
18.8%
3/16 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Investigations
Hyperglycemia
|
0.00%
0/4
|
31.2%
5/16 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hyperkalemia
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypermagnesemia
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypoalbuminemia
|
75.0%
3/4 • Number of events 3
|
100.0%
16/16 • Number of events 16
|
100.0%
6/6 • Number of events 6
|
|
Investigations
Hypocalcemia
|
75.0%
3/4 • Number of events 3
|
75.0%
12/16 • Number of events 12
|
83.3%
5/6 • Number of events 5
|
|
Investigations
Hypokalemia
|
50.0%
2/4 • Number of events 2
|
50.0%
8/16 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypomagnesemia
|
25.0%
1/4 • Number of events 1
|
37.5%
6/16 • Number of events 6
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Hyponatremia
|
50.0%
2/4 • Number of events 2
|
81.2%
13/16 • Number of events 13
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Hypophosphatemia
|
50.0%
2/4 • Number of events 2
|
93.8%
15/16 • Number of events 15
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Proteinuria
|
0.00%
0/4
|
25.0%
4/16 • Number of events 4
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
|
37.5%
6/16 • Number of events 6
|
0.00%
0/6
|
|
Nervous system disorders
Mood alteration
|
0.00%
0/4
|
18.8%
3/16 • Number of events 3
|
0.00%
0/6
|
|
General disorders
Pain - Musculoskeletal
|
25.0%
1/4 • Number of events 1
|
25.0%
4/16 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Pain - Neurology
|
0.00%
0/4
|
43.8%
7/16 • Number of events 7
|
0.00%
0/6
|
|
General disorders
Pain - Other
|
0.00%
0/4
|
12.5%
2/16 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain - Pulmonary
|
25.0%
1/4 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2
|
18.8%
3/16 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/16
|
33.3%
2/6 • Number of events 2
|
|
Renal and urinary disorders
Renal - Other - Decreased urine output
|
0.00%
0/4
|
6.2%
1/16 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60