AzTrials
AzTrials

CancerPhase 1NCT02751528

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

A Phase 1 study testing ETBX-021 in people with Cancer, run by NantBioScience, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
ETBX-021
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
4 Mar 2017to 16 Aug 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Male or female.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB)'s guidelines.
  • Histologically confirmed unresectable locally advanced or metastatic breast cancer that expresses HER2 (IHC 1+ or 2+), derived from the most recent metastatic biopsy sample available.
  • Tumor tissue (block or slides) and whole blood sample available for analysis. Archival tissue is permitted.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Show all 24Show fewer
  • Concurrent hormone therapy is permitted.
  • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
  • Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to NCI CTCAE Grade ≤ 1.
  • Subjects who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
  • Adequate hematologic function at screening, as follows:
  • White blood count ≥ 3000/microliter.
  • Hemoglobin ≥ 9 g/dL (may not transfuse or use erythropoietin to achieve this level).
  • Platelets ≥ 75,000/microliter.
  • Prothrombin (PT)-international normalized ratio (INR) < 1.5.
  • Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN).
  • Adequate renal and hepatic function at screening, as follows:
  • Serum creatinine < 2.0 mg/dL.
  • Bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL).
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN.
  • Multigated acquisition (MUGA) scan or echocardiogram with LVEF ≥ institutional LLN. Same imaging modality is to be used throughout the study.
  • Female subjects of childbearing potential and women < 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and for 7 months following the last injection of study medication. If employing contraception, two of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, condom and spermicidal (gel/foam/cream/vaginal suppository), or total abstinence. Male subjects must be surgically sterile or must agree to use a condom and acceptable contraceptive method with their partner. Female subjects who are post-menopausal are defined as those with an absence of menses for > 12 consecutive months.
  • Ability to attend required study visits and return for adequate follow up, as required by this protocol.

Who cannot join

  • Subjects with HER2 IHC 3+ tumors, or IHC 2+ with an in situ hybridization (ISH) test result considered positive of HER2 amplification by ASCO-CAP HER2 test guidelines.
  • Subjects with ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
  • Participation in an investigational drug or device study within 30 days of screening for this study.
  • Pregnant and nursing women.
  • Subjects with ongoing palbociclib, everolimus, or other breast cancer therapy that interferes with the induction of immune responses.
  • Subjects with concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
Show all 17Show fewer
  • Active brain or central nervous system metastasis, seizures requiring anticonvulsant treatment, cerebrovascular accident (< 6 months), or transient ischemic attack.
  • Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune-related thyroid disease and vitiligo are permitted.
  • Subjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatment.
  • Subjects with a history of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly controlled angina, or history (< 1 year) of ventricular arrhythmia.
  • Subjects with a medical or psychological impediment that would impair the ability of the subject to receive therapy per protocol or impact ability to comply with the protocol or protocol-required visits and procedures.
  • History of malignancy except for the following: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, or other carcinoma that has been in complete remission without treatment for more than 5 years.
  • Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV, as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by western blot) and hepatitis B and hepatitis C virus (HBV/HCV, as determined by HBsAg and hepatitis C serology).
  • Subjects on systemic intravenous or oral steroid therapy (or other immunosuppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had at least 6 weeks of discontinuation of any steroid therapy (except that used as premedication for chemotherapy or contrast-enhanced studies) prior to enrollment.
  • Subjects with known allergy or hypersensitivity to any component of the investigational product will be excluded.
  • Subjects with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
  • Subjects vaccinated with a live (attenuated) vaccine (e.g., FluMist®) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX®, Fluzone®) within 28 days or 14 days, respectively, of the first planned dose of ETBX-021.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

Other trials in United States

About this study

Official title: Phase I Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Low-Expressing (IHC 1+/2+) Breast Cancer

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.

Read the detailed description

This is a Phase I trial in subjects with unresectable locally advanced or metastatic HER2-low expressing (IHC 1+ or 2+) breast cancer. The study will be conducted in two parts: the first part will involve dose escalation using a 3 + 3 design, and the second part will involve the expansion of the MTD or HTD to further evaluate safety, preliminary efficacy, and immunogenicity. In the first part, 3 to 6 subjects will be sequentially enrolled starting at dose cohort 1. Subjects will be assessed for dose-limiting toxicities (DLTs).

Conditions
Cancer
Being tested
ETBX-021
Keywords
Breast Cancer, Breast Cancer male, Breast Neoplasms, Breast Neoplasms male, Vaccine, HER2, Metastatic, Locally Advanced, Unresectable, Solid Tumor, Phase 1, Cancer Vaccine
Medical subject headings
Neoplasms, Breast Neoplasms, Breast Neoplasms, Male, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETBX-021Biological

    Also called Ad5 [E1-, E2b-]-HER2/neu Vaccine, Suspension for Injection

    ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.

Study groups in NCT02751528
Study groupRoleWhat they receive
ETBX-021ExperimentalAd5 [E1-, E2b-]-HER2/neu Vaccine, Suspension for Injection
Receives: Biological: ETBX-021

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 12 months

  2. Determine the Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD)

    Measured: Up to 11 months

Secondary outcomes (5)

  1. ORR (Confirmed Complete or Partial Response)

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

    Measured: Up to 11 months

  2. Disease Control Rate (DCR)

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

    Measured: Up to 11 months

  3. 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).

    Measured: Up to 11 months

  4. Progression Disease Survival

    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.

    Measured: Up to 2 years

  5. Overall Survival

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

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study start4 Mar 2017
  3. Primary completion16 Aug 2018
  4. Study completion16 Aug 2018

Why it stopped: Due to low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02751528
Sponsor's protocol ID
QUILT-3.013
Status last verified
Apr 2024
First submitted
11 Apr 2016
Last updated
13 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ETBX-021 in people with Cancer, run by NantBioScience, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02751528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in