QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA
A Phase I/II Study of Active Immunotherapy With Ad5 [E1-,E2b-]-CEA(6D) Vaccine in Patients With Advanced or Metastatic Malignancies Expressing CEA
1 other identifier
interventional
43
1 country
2
Brief Summary
The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 \[E1-, E2b-\]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Jul 2010
Longer than P75 for phase_1 colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
July 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedResults Posted
Study results publicly available
November 25, 2025
CompletedNovember 25, 2025
November 1, 2025
6.9 years
June 15, 2010
October 25, 2016
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose Limiting Toxicities
The primary objective of this protocol is to determine the safety of immunization with Ad5 \[E1-, E2b-\]-CEA(6D) in patients with advanced or metastatic CEA-expressing malignancies. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients).
Every 3 weeks for 9 weeks and every 3 months for 1 year
Number of Participants With Adverse Events
from the time of first dose to the 30 days past last dose of study drug, up to 330 days
Secondary Outcomes (3)
Clinical Response Rate
from first dose up to a year follow up
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Baseline (Week 0) up to Week 9
CEA Antibody (ng/mL) by Visit
Baseline (Week 0) to Week 9
Study Arms (6)
Cohort 1
EXPERIMENTALCohort 1: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^9 particles
Cohort 2
EXPERIMENTALCohort 2: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^10 particles
Cohort 3
EXPERIMENTALCohort 3: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
Cohort 4
EXPERIMENTALCohort 4 (Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
Cohort 5
EXPERIMENTALCohort 5: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 5 x 10\^11 particles
Cohort 6
EXPERIMENTALCohort 6: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 5 x 10\^11 particles
Interventions
Ad5 \[E1-, E2b-\]-CEA(6D) Vector Vaccine
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of malignancy expressing CEA. Because this is a safety and immunogenicity study, patients are NOT required to have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- For all tumor types other than colorectal, the tumor must express CEA as defined by immunohistochemical staining (at least 50% of the tumor with at least moderate intensity of staining) or a tumor known to be universally CEA positive (i.e. colon and rectal cancer). If colorectal cancer then, pathologic or clinical confirmation of adenocarcinoma is required.
- Patients must have received treatment with standard therapy known to have a possible overall survival benefit.
- For the following common cancers, the following eligibility criteria apply:
- Colorectal cancer: Must have received and progressed through at least one line of palliative chemotherapy consisting of one of the following regimens:
- Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and oxaliplatin.
- Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and irinotecan.
- Palliative chemotherapy regimen for metastatic colorectal cancer that includes bevacizumab.
- Colorectal cancer patients currently receiving palliative single-agent bevacizumab or cetuximab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
- Breast cancer: Must have received and progressed through at least one line of chemotherapy for metastatic breast cancer consisting of one of the following regimens:
- Palliative anthracycline- or taxane-based chemotherapy
- Patients with tumors that over express HER2 (IHC 3+ or FISH+) must have received and progressed through at least one line of palliative therapy that combines trastuzumab with chemotherapy.
- Breast cancer patients currently receiving palliative endocrine therapy or single-agent trastuzumab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
- Patients who have been treated or offered the options of treatment with Bevacizumab (option clearly stated in the consent form).
- Patients who have been treated or offered the options of treatment with Lapatinib (option clearly stated in the consent form).
- +17 more criteria
You may not qualify if:
- Patients with a history of or current brain metastases will not be permitted.
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
- Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
- Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immunosuppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- Patients on steroid therapy (or other immunosuppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
- Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
- Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
- Patients will be allowed warfarin 1mg po qd other than for port prophylaxis.
- Patients with metastatic disease which is determined to be resectable will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NantCell, Inc.lead
Study Sites (2)
Duke Cancer Research Institute, Duke University
Durham, North Carolina, 27710, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
Related Publications (2)
Morse MA, Chaudhry A, Gabitzsch ES, Hobeika AC, Osada T, Clay TM, Amalfitano A, Burnett BK, Devi GR, Hsu DS, Xu Y, Balcaitis S, Dua R, Nguyen S, Balint JP Jr, Jones FR, Lyerly HK. Novel adenoviral vector induces T-cell responses despite anti-adenoviral neutralizing antibodies in colorectal cancer patients. Cancer Immunol Immunother. 2013 Aug;62(8):1293-301. doi: 10.1007/s00262-013-1400-3. Epub 2013 Apr 30.
PMID: 23624851RESULTBalint JP, Gabitzsch ES, Rice A, Latchman Y, Xu Y, Messerschmidt GL, Chaudhry A, Morse MA, Jones FR. Extended evaluation of a phase 1/2 trial on dosing, safety, immunogenicity, and overall survival after immunizations with an advanced-generation Ad5 [E1-, E2b-]-CEA(6D) vaccine in late-stage colorectal cancer. Cancer Immunol Immunother. 2015 Aug;64(8):977-87. doi: 10.1007/s00262-015-1706-4. Epub 2015 May 9.
PMID: 25956394RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sandeep Bobby Reddy, Chief Medical Officer
- Organization
- ImmunityBio
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 22, 2010
Study Start
July 16, 2010
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
November 25, 2025
Results First Posted
November 25, 2025
Record last verified: 2025-11