A Phase 1 interventional study of ETBX-051; adenoviral brachyury vaccine and ETBX-061; adenoviral Mucin-1 (MUC1) vaccine in Neoplasms, Prostate Cancer and Lung Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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Background:
ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune system to target and kill cancer cells. The vaccines target 3 proteins found in many types of cancer. Researchers think targeting all 3 proteins in unison will have the best results.
Objective:
To test the safety of combining ETBX-011, ETBX-061, and ETBX-051 and their effects on the immune system.
Eligibility:
People ages 18 and older with advanced cancer that has not responded to standard therapies
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Scan: They will lie in a machine that takes pictures of the body.
Participants will receive the 3 vaccines through 3 shots under the skin every 3 weeks for 3 doses, then every 8 weeks for up to 1 year. They will have blood and urine tests at each vaccine visit. They will have scans and other measurements of their tumor after 9 weeks and then at their vaccine visits every 8 weeks.
Participants will keep a diary of symptoms at the injection site.
Participants will have a visit 90 days after their final treatment. This will include a physical exam and blood and urine tests. If they have any ongoing side effects, they will be followed until these end or are not changing.
After this visit, they will be called every 3 months for the first year, every 6 months for the next 2 years, then every 12 months for another 2 years to see how they are doing.
Participants will have the option to enroll in a long-term follow-up study.
...
Background:
Objectives:
-To determine the overall safety and recommended phase 2 dose of a combination of three immunotherapeutic vaccines (ETBX-011/ETBX-061/ETBX-051), when administered subcutaneously (SC) to subjects with advanced solid tumors
Eligibility:
Design:
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's enrollment of 11 is below the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Resolution of side effects of prior chemotherapy, radiotherapy, immunotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events () Grade less than or equal to 1 or grade less than or equal to 2 for neuropathy.
Adequate renal and hepatic function at screening, as follows:
Serum creatinine less than or equal to 1.5 x (ULN) OR (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula below):
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose De-Escalation
Biological: ETBX-051; adenoviral brachyury vaccine · Biological: ETBX-061; adenoviral Mucin-1 (MUC1) vaccine · Biological: ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine
Dose Expansion
Biological: ETBX-051; adenoviral brachyury vaccine · Biological: ETBX-061; adenoviral Mucin-1 (MUC1) vaccine · Biological: ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine
immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
Number of Participants With Serious and Non-serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 16 months and 6 days.
Recommended Phase 2 Dose (RP2D)
RP2D is defined as ≤ 1 of 6 of the initial 6 subjects who experience a dose limiting toxicity (DLT), than this dose level will be defined as the RP2D. A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.
Time frame: RP2D was based upon evaluation of DLTs. Participants were followed for DLTs from the first dose of vaccine for 3 weeks.
Number of Participants Who Achieve an Objective Confirmed Complete or Partial Response Assessed by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Objective response is determined by participants whose tumors shrunk after therapy assessed by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Approximately 3.5 months
Number of Patients With Disease Control (Confirmed Response or Stable Disease (SD)) Lasting for at Least 6 Months
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (taking as reference the smallest sum diameters while on study).
Time frame: up to 6 months
Progression-free Survival (PFS)
The amount of time a subject survives without disease progression after treatment. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm. (Note: the appearance of one or more lesions is also considered progression).
Time frame: up to 12 months
Overall Survival (OS)
OS is defined as the amount of time a subject survives after therapy assessed from the date of first treatment to the date of death (any cause).
Time frame: up to 12 months
Number of Participants With a Positive Mucin-1 (MUC-1) Specific T-Cells Immune Response
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
Time frame: up to week 6
Number of Participants With a Positive Carcinoembryonic Antigen (CEA) Specific T-Cells Immune Response
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
Time frame: up to week 6
Number of Participants With a Positive Brachyury Specific T-Cells Immune Response
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
Time frame: up to week 6
Number of Dose Limiting Toxicities (DLTs)
A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.
Time frame: From the date of the first dose of vaccine, approximately 3 weeks.
| Milestone | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 4 |
| Not completed | 0 | 1 |
| Withdrew: Screen failure | 0 | 1 |
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | 6 | 4 |
RP2D is defined as ≤ 1 of 6 of the initial 6 subjects who experience a dose limiting toxicity (DLT), than this dose level will be defined as the RP2D. A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.
| billion viral particles per indiv. vacc. | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|
| Recommended Phase 2 Dose (RP2D) | 500 |
Objective response is determined by participants whose tumors shrunk after therapy assessed by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Confirmed Complete Response | 0 | 0 |
| Partial Response | 0 | 0 |
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (taking as reference the smallest sum diameters while on study).
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Patients With Disease Control (Confirmed Response or Stable Disease (SD)) Lasting for at Least 6 Months | 1 | 1 |
The amount of time a subject survives without disease progression after treatment. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm. (Note: the appearance of one or more lesions is also considered progression).
| weeks | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Progression-free Survival (PFS) | 10 (3 to 22) | 9 (6 to 30) |
OS is defined as the amount of time a subject survives after therapy assessed from the date of first treatment to the date of death (any cause).
| months | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Overall Survival (OS) | 9.5 (2.0 to NA) | 9.5 (5.0 to NA) |
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Participants With a Positive Mucin-1 (MUC-1) Specific T-Cells Immune Response | 3 | 3 |
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Participants With a Positive Carcinoembryonic Antigen (CEA) Specific T-Cells Immune Response | 2 | 2 |
Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.
| Participants | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Participants With a Positive Brachyury Specific T-Cells Immune Response | 1 | 2 |
A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.
| Toxicities | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Number of Dose Limiting Toxicities (DLTs) | 0 | 0 |
Collected over Date treatment consent signed to date off study, approximately 16 months and 6 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | 1/6 (16.7%) | 2/6 (33.3%) | 6/6 (100%) |
| Expansion Cohort - 5 x 10^11 Viral Particles (VP) | 3/4 (75%) | 0/4 (0%) | 4/4 (100%) |
| Event | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Abdominal painGastrointestinal disorders | 1/6 | 0/4 |
| FeverGeneral disorders | 1/6 | 0/4 |
| Infections and Infestations - Other, Gram-negative bacteremia, 40 degree C feverInfections and infestations | 1/6 | 0/4 |
| Death, NOSGeneral disorders | 1/6 | 0/4 |
| Event | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) |
|---|---|---|
| Injection site reactionGeneral disorders | 6/6 | 4/4 |
| PainGeneral disorders | 5/6 | 4/4 |
| Flu like symptomsGeneral disorders | 5/6 | 3/4 |
| FatigueGeneral disorders | 4/6 | 0/4 |
| FeverGeneral disorders | 3/6 | 2/4 |
| AnorexiaMetabolism and nutrition disorders | 2/6 | 1/4 |
| Upper respiratory infectionInfections and infestations | 2/6 | 0/4 |
| Abdominal painGastrointestinal disorders | 0/6 | 1/4 |
| BloatingGastrointestinal disorders | 1/6 | 1/4 |
| ConstipationGastrointestinal disorders | 1/6 | 1/4 |
| Age, Categorical(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| Mean | 50.3 ± 8.1 | 48.6 ± 12.9 | 49.5 ± 10.6 |
| Sex: Female, Male(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| Female | 6 | 0 | 6 |
| Male | 0 | 5 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 5 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| United States | 6 | 5 | 11 |
| Number of Participants with Adenovirus 5-Neutralizing Antibodies(Participants) | Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP) | Expansion Cohort - 5 x 10^11 Viral Particles (VP) | Total |
|---|---|---|---|
| Count of participants | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in May 2018, 3 months.
Results were first posted in Dec 2019, 1 year 7 months after primary completion.
Of 227 non-industry phase 1 interventional studies under Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 88. This study's 3 months is below that.
Counting every sponsor, half of 904 studies reached it within 40 months; a quarter within 23 and three quarters within 64.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ETBX-011
National Cancer Institute (NCI) →