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low enrollment
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QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.
NANT Colorectal Cancer (CRC) Vaccine: A phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects with Metastatic CRC Who Have Been Previously Treated with Standard-Of-Care Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NANT Colorectal Cancer (CRC) Vaccine | Experimental | A combination of agents will be administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. |
|
| Regorafenib | Active Comparator | Regorafenib will be administered to subjects in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldoxorubicin Hydrochloride | Biological | Aldoxorubicin Hydrochloride HCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | 30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate by RECIST Version 1.1 and irRC | 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed. |
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Inclusion Criteria:
Age ≥ 18 years.
Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
Histologically-confirmed recurrent or metastatic CRC previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy; or subjects who are ineligible for these therapies.
ECOG performance status of 0 or 1.
Have at least 1 measurable lesion of ≥ 1.0 cm.
Must have a recent FFPE tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. 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.
Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, 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, IUDs, and abstinence.
Phase 2 single-arm component only
Must have progressed on or after regorafenib treatment in the randomized phase 2 portion of the study OR progressed or experienced unacceptable toxicity on SoC and regorafenib prior to enrollment on the study.
Exclusion Criteria:
MSI-high or MMR-deficient tumors eligible for, but not yet treated with, a PD-1 inhibitor.
Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs 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, or 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:
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 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 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 CYP3A4 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 screening for 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.
Phase 2 randomized component only
Prior regorafenib treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chan Soon-Shiong Institute for Medicine | El Segundo | California | 90245 | United States |
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Eligible participants could have gone through both induction and maintenance treatment on study.
All subjects were treated on the same arm and not randomized in the Phase 1b portion of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | NANT Colorectal Cancer (CRC) Vaccine | A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1] ETBX-011: Ad5 [E1-, E2b-]-CEA ETBX-021: Ad5 [E1-, E2b-]-[HER2] ETBX-051: Ad5 [E1-, E2b-]-Brachyury ETBX-061: Ad5 [E1-, E2b-]-mucin 1 [MUC1] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 [CD16.158V, ER IL-2] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2018 |
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| ALT-803 | Biological | Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1] |
|
| ETBX-011 | Biological | Ad5 [E1-, E2b-]-CEA |
|
| ETBX-021 | Biological | Ad5 [E1-, E2b-]-[HER2] |
|
| ETBX-051 | Biological | Ad5 [E1-, E2b-]-Brachyury |
|
| ETBX-061 | Biological | Ad5 [E1-, E2b-]-mucin 1 [MUC1] |
|
| GI-4000 | Biological | RAS yeast |
|
| GI-6207 | Biological | CEA yeast |
|
| GI-6301 | Biological | Brachyury yeast |
|
| haNK | Biological | haNKâ„¢, NK-92 [CD16.158V, ER IL-2] |
|
| Avelumab | Drug | BAVENCIO® injection |
|
| Capecitabine | Drug | XELODA® tablets |
|
| Cetuximab | Drug | ERBITUX® injection |
|
| Cyclophosphamide | Drug | Cyclophosphamide Capsules |
|
| 5-Fluorouracil | Drug | 5-FU; Fluorouracil Injection |
|
| Leucovorin | Drug | Leucovorin Calcium |
|
| Nab-paclitaxel | Drug | ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound] |
|
| Oxaliplatin | Drug | ELOXATIN® injection |
|
| Regorafenib | Drug | STIVARGA® tablets |
|
| SBRT | Procedure | Stereotactic body radiation therapy |
|
| 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 4 months |
| Progression Free Survival by RECIST Version 1.1 and irRC | PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy. | 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 9 months. |
| Duration of Response (DOR) by RECIST Version 1.1 and irRC | DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy. | 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 4 months |
| Overall Survival | OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive. | Participants were assessed from screening to death. |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | 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 4 months |
| Quality of Life by Patient Reported Outcomes (PRO) | PROs were assessed using the Functional Assessment of Cancer Therapy-colorectal cancer (FACT-C) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-36 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale. | Assessments occurred at Baseline, Cycle 2 Day 8 (C2D8), Cycle 5 Day 1 (C5D1), at an unscheduled visit prior to end of treatment, and at end of treatment (up to 5 months). Each cycle was 28 days. |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | 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 4 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NANT Colorectal Cancer (CRC) Vaccine | A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1] ETBX-011: Ad5 [E1-, E2b-]-CEA ETBX-021: Ad5 [E1-, E2b-]-[HER2] ETBX-051: Ad5 [E1-, E2b-]-Brachyury ETBX-061: Ad5 [E1-, E2b-]-mucin 1 [MUC1] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 [CD16.158V, ER IL-2] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| SUBJECTS WITH METASTATIC CRC WHO HAVE BEEN PREVIOUSLY TREATED WITH STANDARD-OF-CARE (SOC) THERAPY | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | Posted | Count of Participants | Participants | 30 days after last dose, up to 6 months or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate by RECIST Version 1.1 and irRC | 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed. | Posted | Count of Participants | Participants | 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 4 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival by RECIST Version 1.1 and irRC | PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy. | Posted | Median | Full Range | Months | 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 9 months. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by RECIST Version 1.1 and irRC | DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy. | There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis. | Posted | 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 4 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive. | Posted | Median | Full Range | Months | Participants were assessed from screening to death. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Posted | Count of Participants | Participants | 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 4 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life by Patient Reported Outcomes (PRO) | PROs were assessed using the Functional Assessment of Cancer Therapy-colorectal cancer (FACT-C) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-36 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale. | The questionnaire was not completed for every patient at every visit. | Posted | Median | Full Range | score on a scale | Assessments occurred at Baseline, Cycle 2 Day 8 (C2D8), Cycle 5 Day 1 (C5D1), at an unscheduled visit prior to end of treatment, and at end of treatment (up to 5 months). Each cycle was 28 days. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Posted | Count of Participants | Participants | 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 4 months |
|
Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 6 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 6 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 6 months.
The numbers of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events are zero in Regorafenib group because there are no subjects enrolled in Regorafenib group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NANT Colorectal Cancer (CRC) Vaccine | A combination of agents was administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT. Aldoxorubicin Hydrochloride: Aldoxorubicin Hydrochloride HCI ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1] ETBX-011: Ad5 [E1-, E2b-]-CEA ETBX-021: Ad5 [E1-, E2b-]-[HER2] ETBX-051: Ad5 [E1-, E2b-]-Brachyury ETBX-061: Ad5 [E1-, E2b-]-mucin 1 [MUC1] GI-4000: RAS yeast GI-6207: CEA yeast GI-6301: Brachyury yeast haNK: haNK™, NK-92 [CD16.158V, ER IL-2] Avelumab: BAVENCIO® injection Capecitabine: XELODA® tablets Cetuximab: ERBITUX® injection Cyclophosphamide: Cyclophosphamide Capsules 5-Fluorouracil: 5-FU; Fluorouracil Injection Leucovorin: Leucovorin Calcium Nab-paclitaxel: ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound] Oxaliplatin: ELOXATIN® injection Regorafenib: STIVARGA® tablets SBRT: Stereotactic body radiation therapy | 2 | 2 | 1 | 2 | 2 | 2 |
| EG001 | Regorafenib | Regorafenib will be administered to subjects in this study. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Injection site reaction | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung opacity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 855-797-9277 | Bobby.Reddy@Immunitybio.com |
| Apr 4, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582303 | ALT-803 |
| C588090 | yeast-CEA vaccine |
| C000609138 | avelumab |
| D000069287 | Capecitabine |
| D000068818 | Cetuximab |
| D003520 | Cyclophosphamide |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000077150 | Oxaliplatin |
| C559147 | regorafenib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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