Triple Negative Breast CancerPhase 1/2NCT03387085
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
A Phase 1/2 study testing Aldoxorubicin HCl, N-803 and ETBX-011 in people with Triple Negative Breast Cancer, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Aldoxorubicin HCl, N-803 and ETBX-011
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 16 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically-confirmed metastatic or unresectable TNBC that has either progressed on or after anthracycline-based chemotherapy (or other approved standard of care therapy) or subject has refused anthracycline-based chemotherapy, or other taxane- and platinum-based therapies. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PR) expression, and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have at least 1 measurable lesion of ≥ 1.0 cm.
- Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
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- Must be willing to provide blood samples prior to the start of treatment on this study.
- Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment, if considered safe by the Investigator.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.
Who cannot join
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results:
- Absolute neutrophil count < 1000 cells/mm3.
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- Platelet count < 75,000 cells/mm3.
- Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).
- Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
- Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
- Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
- Serum creatinine > 2.0 mg/dL or 177 μmol/L.
- Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
- Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
- Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal.
- Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
- Positive results of screening test for human immunodeficiency virus (HIV).
- Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
- Known hypersensitivity to any component of the study medication(s).
- Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
- Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
- Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to initiation of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Concurrent participation in any interventional clinical trial.
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
About this study
Official title: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.
Read the detailed description
Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldoxorubicin HClDrug
Aldoxorubicin hydrochloride
N-803Biological
Recombinant human super agonist interleukin-15 (IL-15) complex
ETBX-011Biological
Ad5 [E1-, E2b-]-CEA
ETBX-051Biological
Ad5 [E1-, E2b-]-Brachyury vaccine
ETBX-061Biological
Ad5 [E1-, E2b-]-MUC1
GI-4000Biological
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
GI-6207Biological
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
GI-6301Biological
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
haNK for InfusionBiological
NK-92 [CD16.158V, ER IL-2]
avelumabBiological
Recombinant human anti-PD-L1 IgG1 monoclonal antibody
bevacizumabBiological
Recombinant human anti-VEGF IgG1 monoclonal
CapecitabineDrug
5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
CisplatinDrug
cis-diamminedichloroplatinum(II)
CyclophosphamideDrug
2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
5-FluorouracilDrug
5-fluoro-2,4 (1H,3H)-pyrimidinedione
LeucovorinDrug
L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
nab-PaclitaxelDrug
Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
SBRTProcedure or surgery
Stereotactic Body Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| NANT triple negative breast cancer (TNBC) Vaccine | Experimental | A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT. Receives: Drug: Aldoxorubicin HCl; Biological: N-803; Biological: ETBX-011; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6207; Biological: GI-6301; Biological: haNK for Infusion; Biological: avelumab; Biological: bevacizumab; Drug: Capecitabine; Drug: Cisplatin; Drug: Cyclophosphamide; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: nab-Paclitaxel; Procedure: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Graded using the NCI CTCAE Version 4.03.
Measured: Up to 2 years
Secondary outcomes (10)
Objective Response Rate by RECIST v1.1
Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Percent of subjects with confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters.
Measured: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 years
Objective Response Rate by irRC (Percent of Subjects With Confirmed Complete or Partial Overall Response)
Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with Response Evaluation Criteria in Solid Tumors (irRC) Version 1.1. Percent of subjects with confirmed complete Response or partial response by irRC.
Measured: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 years.
Progression Free Survival by RECIST v1.1
PFS were defined as the time from the date of first treatment to the date of disease progression or death (any cause), whichever occured first. Subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Measured: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.
Progression Free Survival by irRC
PFS were defined as the time from the date of first treatment to the date of disease progression or death (any cause), whichever occured first. Subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Measured: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Duration of Response by RECIST Version 1.1
DOR were evaluated using Kaplan-Meier methods for those subjects with a confirmed response. DOR were defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occured first. Responding subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in DOR analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Measured: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Disease Control Rate by RECIST Version 1.1
Disease control was defined as subjects with a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting for at least 2 months.
Complete response (CR; disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) or stable disease (SD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD)
Measured: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression. Up to 2.5 years.
Duration of Response by irRC
DOR were evaluated using Kaplan-Meier methods for those subjects with a confirmed response. DOR were defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occured first. Responding subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in DOR analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Measured: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Disease Control Rate by irRC
Disease control was defined as subjects with a confirmed Complete Response (irCR), Partial Response (irPR), or Stable Disease (irSD) lasting for at least 2 months.
Complete response (irCR; disappearance of all index lesions) or partial response (irPR; >=100% decrease in the sum of the longest diameter of index lesions with stable non-index lesions or >=50% decrease in the sum of index lesions with absent/stable /progressed non-index lesions) or stable disease (irSD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD)
Measured: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.
Overall Survival
OS were evaluated using Kaplan-Meier methods. OS were defined as the time from the date of first treatment to the date of death (any cause). Subjects who are alive at the end of follow-up were censored in the OS analysis at the last known date alive.
Measured: Evaluated from screening to death.
Quality of Life by Patient Reported Outcomes
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) instrument on study
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start19 Mar 2018
- Primary completion11 Sep 2020
- Study completion16 Jan 2024
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387085
- Sponsor's protocol ID
- QUILT-3.067
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2017
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
- ClinicalTrials.gov ID
- NCT03387085
- Acronym / sponsor ID
- QUILT-3.067
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.
Detailed description
Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NANT triple negative breast cancer (TNBC) Vaccine | Experimental | Drug: Aldoxorubicin HCl, Biological: N-803, Biological: ETBX-011, Biological: ETBX-051, Biological: ETBX-061, Biological: GI-4000, Biological: GI-6207, Biological: GI-6301, Biological: haNK for Infusion, Biological: avelumab, Biological: bevacizumab, Drug: Capecitabine, Drug: Cisplatin, Drug: Cyclophosphamide, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: nab-Paclitaxel, Procedure: SBRTA combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically-confirmed metastatic or unresectable TNBC that has either progressed on or after anthracycline-based chemotherapy (or other approved standard of care therapy) or subject has refused anthracycline-based chemotherapy, or other taxane- and platinum-based therapies. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PR) expression, and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have at least 1 measurable lesion of ≥ 1.0 cm.
Key exclusion criteria (26 listed)
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aldoxorubicin HClAldoxorubicin hydrochloride | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| N-803Recombinant human super agonist interleukin-15 (IL-15) complex | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| ETBX-011Ad5 [E1-, E2b-]-CEA | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| ETBX-051Ad5 [E1-, E2b-]-Brachyury vaccine | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| ETBX-061Ad5 [E1-, E2b-]-MUC1 | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| GI-4000Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| GI-6207Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| GI-6301Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| haNK for InfusionNK-92 [CD16.158V, ER IL-2] | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| avelumabRecombinant human anti-PD-L1 IgG1 monoclonal antibody | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| bevacizumabRecombinant human anti-VEGF IgG1 monoclonal | Biological | NANT triple negative breast cancer (TNBC) Vaccine |
| Capecitabine5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| Cisplatincis-diamminedichloroplatinum(II) | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| Cyclophosphamide2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| 5-Fluorouracil5-fluoro-2,4 (1H,3H)-pyrimidinedione | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| LeucovorinL-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| nab-PaclitaxelBenzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin | Drug | NANT triple negative breast cancer (TNBC) Vaccine |
| SBRTStereotactic Body Radiation Therapy | Procedure or surgery | NANT triple negative breast cancer (TNBC) Vaccine |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to 2 years
Graded using the NCI CTCAE Version 4.03.
10 secondary outcomes
Objective Response Rate by RECIST v1.1
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 years
Objective Response Rate by irRC (Percent of Subjects With Confirmed Complete or Partial Overall Response)
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 years.
Progression Free Survival by RECIST v1.1
Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.
Progression Free Survival by irRC
Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Duration of Response by RECIST Version 1.1
Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Disease Control Rate by RECIST Version 1.1
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression. Up to 2.5 years.
Duration of Response by irRC
Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Disease Control Rate by irRC
Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.
Overall Survival
Time frame: Evaluated from screening to death.
Quality of Life by Patient Reported Outcomes
Time frame: Up to 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aldoxorubicin HCl, N-803 and ETBX-011 in people with Triple Negative Breast Cancer, run by ImmunityBio, 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 10 inclusion and 26 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 9 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 9 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 Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.