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Thyroid CancerPhase 1/2NCT03127098

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

A Phase 1/2 study testing ETBX-011 and ALT-803 in people with Thyroid Cancer and Colon Cancer, run by NantCell, Inc. at 1 site in United States.

Terminated

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

Official record
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Trial summary

This is a phase 1b/2 study to evaluate the safety, tolerability, and efficacy of ETBX-011 vaccine used in combination with ALT-803 in subjects with locally advanced or metastatic CEA-expressing cancers whose tumor has recurred after standard-of-care treatment. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Thyroid Cancer, Colon Cancer, Ovarian Cancer
What is being tested?
ETBX-011 and ALT-803
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
26 Jun 2017to 7 Dec 2017
Phase
Phase 1/2
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥ 21 years.
  • Subjects with a histologically confirmed diagnosis of locally advanced or metastatic malignancy who were previously treated with at least one method of standard therapy known to have a possible survival benefit or refused such therapy.
  • The tumor must express CEA or must be known to be universally CEA positive (ie, colon and rectal cancer).
  • Must have a recent FFPE tumor biopsy specimen.
  • Subjects who have received prior CEA-targeted immunotherapy (eg, vaccine or antibody) 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.
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  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB)'s guidelines.
  • ECOG performance status of 0 or 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:
  • WBC 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 × 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 × ULN.
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
  • 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. Male subjects must be surgically sterile or must agree to use a condom and acceptable contraceptive method with their partner.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.

Who cannot join

  • Participation in an investigational drug or device study within 30 days of screening for this study.
  • Pregnant and nursing women.
  • Subjects with ongoing everolimus or other cancer therapy that interferes with the induction of immune responses.
  • Subjects with concurrent cytotoxic chemotherapy or radiation therapy. There must be at least one (1) month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior CEA-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.
  • 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.
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  • 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-011 or ALT 803.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical Oncology Associates

    Spokane, Washington, 99208

Other trials in United States

About this study

Official title: Phase 1b/2 Study of ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer

This is a phase 1b/2 study to evaluate the safety, tolerability, and efficacy of ETBX-011 vaccine used in combination with ALT-803 in subjects with locally advanced or metastatic CEA-expressing cancers whose tumor has recurred after standard-of-care treatment.

Read the detailed description

The trial will consist of a phase 1b study with ETBX-011 as a fixed dose with a dose escalation of ALT-803 unless de-escalation is required. The proposed phase 2 expansion study will give additional safety data for the MTD as well as preliminary efficacy data. Subjects will receive treatments unless they experience progressive disease, dose-limiting toxicities (DLT), withdraw consent, or if the investigator determines it is no longer in their best medical interest to continue treatment.

Being tested
ETBX-011, ALT-803
Keywords
locally advanced or metastatic, carcinoembryonic antigen (CEA)-expressing, CEA, carcinoembryonic antigen
Medical subject headings
Thyroid Neoplasms, Colonic Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • ETBX-011Biological

    Also called Ad5 [E1-, E2b-]-CEA(6D)

    ETBX-011 immunization was administered by subcutaneous (SC) injection.

  • ALT-803Biological

    Also called Super-agonist IL-15, IL-15

    ALT-803 was administered by SC injection.

Study groups in NCT03127098
Study groupRoleWhat they receive
ETBX-011 in combination with ALT-803ExperimentalA combination of agents were administered to subjects in this dose-escalation study
Receives: Biological: ETBX-011; Biological: ALT-803

What is being measured

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

  1. Number of Participants With Dose-Limiting Toxicities

    Measured: 9 weeks

Secondary outcomes (3)

  1. Duration of Response

    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).

    Measured: Up to 11 weeks

  2. Progression Free 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. 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.

    Measured: Up to 11 weeks

  3. Overall Survival

    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.

    Measured: Up to 6 months

Timeline

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

  1. First posted25 Apr 2017
  2. Study start26 Jun 2017
  3. Primary completion7 Dec 2017
  4. Study completion7 Dec 2017

Why it stopped: The study was terminated before any dose escalation occurred in order to pursue other studies designed to more extensively evaluate the combination of ETBX-011 and N-803 along with other immunotherapy agents.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
ETBX-011 immunization was administered by subcutaneous (SC) injection. ALT-803 will be administered by SC injection.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127098
Sponsor's protocol ID
QUILT-3.040
Status last verified
Aug 2019
First submitted
20 Apr 2017
Last updated
6 Aug 2024
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 1/2 study testing ETBX-011 and ALT-803 in people with Thyroid Cancer and Colon Cancer, run by NantCell, Inc. at 1 site 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 22 inclusion and 15 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Aug 2024). 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 Dose-Limiting Toxicities (time frame: 9 weeks). 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 NCT03127098.

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 6 Aug 2024.

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