Trial Outcomes & Findings for QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer (NCT NCT02751528)

NCT ID: NCT02751528

Last Updated: 2025-01-13

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2025-01-13

Participant Flow

Participant milestones

Measure	5 x 10^10 VP Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	5 x 10^10 VP Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer

Baseline characteristics by cohort

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Age, Continuous	60.7 years STANDARD_DEVIATION 3.21 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Histologically confirmed unresectable locally advanced or metastatic breast cancer that expresses HE	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Number of Participants With Treatment-emergent Adverse Events, Number of Participants With Treatment Emergent Serious Adverse Events, and Number of Participants With Dose Limiting Toxicities (DLTs) TEAE	3 Participants
Number of Participants With Treatment-emergent Adverse Events, Number of Participants With Treatment Emergent Serious Adverse Events, and Number of Participants With Dose Limiting Toxicities (DLTs) TESAE	1 Participants
Number of Participants With Treatment-emergent Adverse Events, Number of Participants With Treatment Emergent Serious Adverse Events, and Number of Participants With Dose Limiting Toxicities (DLTs) DLT	0 Participants

PRIMARY outcome

Timeframe: Up to 11 months

Population: MTD / HTD not reached due to early termination of the study

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Determine the Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD)	NA virus particles MTD / HTD not reached due to early termination of the study

SECONDARY outcome

Timeframe: Up to 11 months

ORR assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
ORR (Confirmed Complete or Partial Response)	0 Participants

SECONDARY outcome

Timeframe: Up to 11 months

Confirmed response or stable disease lasting for at least 6 months according to RECIST V1.1

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Disease Control Rate (DCR)	1 Participants

SECONDARY outcome

Timeframe: Up to 11 months

Population: Best overall response was Stable Disease, which did not meet the criteria for duration of response.

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started).

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Duration of Response	NA Months Best overall response was Stable Disease, which did not meet the criteria for duration of response.

SECONDARY outcome

Timeframe: Up to 2 years

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.

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Progression Disease Survival	NA Months Interval 1.7 to N/A - Median time and upper limit of 95% CI were not reached.

SECONDARY outcome

Timeframe: Up to 2 years

OS will be defined as the time from the date of first treatment to the date of death (any cause).

Outcome measures

Measure	5 x 10^10 VP n=3 Participants Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Overall Survival	NA Months Interval 1.7 to N/A - Median time and upper limit of 95% CI were not reached.

Adverse Events

5 x 10^10 VP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	5 x 10^10 VP n=3 participants at risk Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.

Other adverse events

Measure	5 x 10^10 VP n=3 participants at risk Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection ETBX-021: ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
General disorders Injection site reaction	66.7% 2/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
General disorders Pyrexia	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Gastrointestinal disorders Constipation	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Gastrointestinal disorders Nausea	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Gastrointestinal disorders Oral dysaesthesia	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Investigations Weight decreased	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Psychiatric disorders Anxiety	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Psychiatric disorders Insomnia	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.
Vascular disorders Hot flush	33.3% 1/3 • Non-serious AEs were followed for 30 days after the subject's last dose of the study drug, up to 12 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 12 months. All SAEs that have not resolved upon discontinuation of the subject's participation in the study must be followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow up, or otherwise explained, up to 12 months.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@immunitybio.com

Results disclosure agreements

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