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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
Phase 1 trial testing ETBX-021 in Cancer in 3 participants. Terminated before completion.
| Lead sponsor | NantBioScience, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 4 March 2017 |
| Primary completion | 16 August 2018 |
| Estimated completion | 16 August 2018 |
| Sites | 2 locations across United States |
NantBioScience, Inc. — full company profile →
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | 3 |
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | 1 |
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | 0 |
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | NA |
ORR assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
| Group | Value | 95% CI |
|---|---|---|
| ETBX-021 | 0 |
Confirmed response or stable disease lasting for at least 6 months according to RECIST V1.1
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | 1 |
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).
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | NA |
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.
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | NA | 1.7 – NA |
OS will be defined as the time from the date of first treatment to the date of death (any cause).
| Group | Value | 95% CI |
|---|---|---|
| 5 x 10^10 VP | NA | 1.7 – NA |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 5 x 10^10 VP |
|---|---|---|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | 5 x 10^10 VP |
|---|---|---|
| Injection site reaction | General disorders | — |
| Pyrexia | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Oral dysaesthesia | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | — |
| Weight decreased | Investigations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Anxiety | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Hot flush | Vascular disorders | — |
Most-reported serious reactions: Cancer pain, Respiratory failure.
Data from ClinicalTrials.gov NCT02751528 adverse events section.
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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