Trial Outcomes & Findings for QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer (NCT NCT03127098)
NCT ID: NCT03127098
Last Updated: 2024-08-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
9 weeks
Results posted on
2024-08-06
Participant Flow
Only the first dose level, N-803 10 μg/kg/dose + ETBX-011 (5 × 10\^11 VP/dose), was administered due to study termination. No additional escalations or the expansion phase (Phase 2) occurred. No patients had a response, therefore, Duration of Response could not be summarized. Only 2 out of 3 enrolled patients had a response assessment data, therefore, Progression Free Survival and Overall Survival analyses will not provide a meaningful result.
Participant milestones
| Measure |
ETBX-011 in Combination With ALT-803
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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3
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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
QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer
Baseline characteristics by cohort
| Measure |
ETBX-011 in Combination With ALT-803
n=3 Participants
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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|---|---|
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Age, Continuous
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63.7 years
STANDARD_DEVIATION 7.57 • 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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2 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Subjects with previously treated locally advanced or metastatic CEA-expressing cancer
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 9 weeksOutcome measures
| Measure |
ETBX-011 in Combination With ALT-803
n=3 Participants
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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|---|---|
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Number of Participants With Dose-Limiting Toxicities
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1 Participants
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SECONDARY outcome
Timeframe: Up to 11 weeksPopulation: No objective responses were observed.
The duration of overall response was measured from the time measurement criteria are met for CR or PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 11 weeksPopulation: No objective responses were observed.
PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurred first. Subjects who did not have disease progression or did not die at the end of follow up were to be censored at the last known date the subject was progression free.
Outcome measures
| Measure |
ETBX-011 in Combination With ALT-803
n=3 Participants
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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|---|---|
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Progression Free Survival
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3 Participants
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SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: No objective responses were observed.
OS was evaluated by dose cohort and overall using the Kaplan-Meier method. OS was defined as the time from the date of first treatment to the date of death from any cause. Subjects who were alive at the end of follow up were to be censored at the last known date alive.
Outcome measures
| Measure |
ETBX-011 in Combination With ALT-803
n=3 Participants
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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|---|---|
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Overall Survival
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NA Months
insufficient number of participants with event
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Adverse Events
ETBX-011 in Combination With ALT-803
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ETBX-011 in Combination With ALT-803
n=3 participants at risk
A combination of agents were administered to subjects in this dose-escalation study
ETBX-011: ETBX-011 immunization was administered by subcutaneous (SC) injection.
ALT-803: ALT-803 was administered by SC injection.
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Blood and lymphatic system disorders
Lymph node pain
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Eye disorders
Visual impairment
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Gastrointestinal disorders
Abdominal pain
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Gastrointestinal disorders
Vomiting
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Asthenia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Chills
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66.7%
2/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Fatigue
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66.7%
2/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Influenza like illness
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66.7%
2/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Injection site erythema
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100.0%
3/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Injection site oedema
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100.0%
3/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Injection site pain
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100.0%
3/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Injection site pruritus
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100.0%
3/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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General disorders
Pyrexia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Musculoskeletal and connective tissue disorders
Arthralgia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Musculoskeletal and connective tissue disorders
Myalgia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Nervous system disorders
Hypoaesthesia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Psychiatric disorders
Insomnia
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Vascular disorders
Flushing
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Vascular disorders
Hot flush
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33.3%
1/3 • Non-serious AEs were to be followed for 30 days after subject's last dose of ETBX-011+ALT-803, up to 13 weeks . Non-serious grade 3/4 AEs were to be followed until resolution or stabilization, up to 13 weeks. All SAEs that did not resolve upon discontinuation of the subject's participation in the study were to be followed until recovered, recovered w/ sequelae, lost to follow-up, otherwise, up to 13 weeks. All-Cause Mortality was assessed through study completion, up to 6 months.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place