Colorectal CancerPhase 1/2NCT01147965
QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA
A Phase 1/2 study testing Ad5 CEA Vaccine in people with Colorectal Cancer and Lung Cancer, run by NantCell, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- Ad5 CEA Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2010to 31 May 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Lung cancer: Must have received and progressed through chemotherapy for metastatic disease consisting of one of the following regimens:
- Palliative platinum-based (cisplatin or carboplatin) chemotherapy if the patient has not received chemotherapy previously.
- Palliative taxane-based (docetaxel or paclitaxel) or vinorelbine chemotherapy if the patient has received chemotherapy previously.
- Lung cancer patients currently receiving palliative single-agent erlotinib or gefitinib 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).
- Pancreatic cancer: Must have received and progressed through chemotherapy including gemcitabine.
- Pancreatic cancer patients currently receiving palliative single-agent erlotinib will be eligible for this trial and may continue this therapy concomitant with study treatment (if they have been on this single agent therapy for at least 3 months).
- For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.
- Patients who have received and progressed through first-line palliative chemotherapy must be advised regarding second-line therapy before being enrolled on this investigational study.
- Karnofsky performance score of 70% or higher
- Estimated life expectancy > 3 months
- Age ≥ 21 years, but < 75
- Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5, PTT <1.5X ULN
- Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
- Patients who have received prior CEA-targeted immunotherapy are eligible for this trial, if this treatment was discontinued at least 3 months prior to enrollment.
- Patients who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
- Ability to return to the clinical site for adequate follow-up, as required by this protocol.
Who cannot join
- Patients with concurrent cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. Except for the permitted concomitant therapies (bevacizumab, cetuximab, trastuzumab, erlotinib, gefitinib, or hormonal therapy which patients must have been on for at least 3 months at the time of enrollment if they intend to continue them with the vaccine), there must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy (including radiotherapy) and study treatment. Patients must have recovered to grade 1 acute toxicities from prior treatment.
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Cancer Research Institute, Duke University
Durham, North Carolina, 27710
Medical Oncology Associates, PS
Spokane, Washington, 99208
About this study
Official title: A Phase I/II Study of Active Immunotherapy With Ad5 [E1-,E2b-]-CEA(6D) Vaccine in Patients With Advanced or Metastatic Malignancies Expressing CEA
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.
Read the detailed description
This is a phase I/II study with the primary purpose to determine the safety of immunization with Ad5 [E1-, E2B-]-CEA(6D), in patients with advanced or metastatic CEA-expressing malignancies. The secondary objectives are to evaluate CEA-specific immune responses to the immunizations and to obtain preliminary data on clinical response rate. The study population consists of patients with a histologically confirmed diagnosis of metastatic malignancy that is CEA positive who were previously treated with standard therapy known to have a possible survival benefit or refused such therapy. The study will determine the safety of three dosage levels of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase I component), and the maximally tolerated dose of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase II component). The study drug is Ad5 [E1-, E2B-]-CEA(6D) given by subcutaneous (SQ) injection every 3 weeks for 3 immunizations. We will evaluate safety in each cohort at least 3 weeks after the last patient in the previous cohort has received their first injection. 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). We are currently enrolling up to 10 additional patients (Cohort 6) to evaluate safety, immunogenicity, and efficacy at the highest dose of vaccine.
- Conditions
- Colorectal Cancer, Lung Cancer, Breast Cancer, Prostate Cancer
- Being tested
- Ad5 CEA Vaccine
- Keywords
- Colon Cancer, Lung Cancer, Breast Cancer, CEA, Prostate Cancer
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5 CEA VaccineBiological
Ad5 [E1-, E2b-]-CEA(6D) Vector Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^9 particles Receives: Biological: Ad5 CEA Vaccine |
| Cohort 2 | Experimental | Cohort 2: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^10 particles Receives: Biological: Ad5 CEA Vaccine |
| Cohort 3 | Experimental | Cohort 3: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^11 particles Receives: Biological: Ad5 CEA Vaccine |
| Cohort 4 | Experimental | Cohort 4 (Phase II Cohort at MTD): Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^11 particles Receives: Biological: Ad5 CEA Vaccine |
| Cohort 5 | Experimental | Cohort 5: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 5 x 10^11 particles Receives: Biological: Ad5 CEA Vaccine |
| Cohort 6 | Experimental | Cohort 6: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 5 x 10^11 particles Receives: Biological: Ad5 CEA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Every 3 weeks for 9 weeks and every 3 months for 1 year
Number of Participants With Adverse Events
Measured: 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
Clinical response was assessed for participants that achieve a clinical response of complete response (CR) or partial response (PR), according to RECISIT criteria (v1.0 for Cohorts 1-5 and v1.1 for Cohort 6). CR is defined as disappearance of all target lesions. PR is defined as >=30% decrease in the sum of the longest diameter of target lesions.
Measured: from first dose up to a year follow up
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Cell mediated immune response was characterized using ELISpot assays performed on Peripheral Blood Mononuclear Cells to determine the number of IFN-gamma secreting cells.
Measured: Baseline (Week 0) up to Week 9
CEA Antibody (ng/mL) by Visit
Summary of CEA Antibody (ng/mL) by Visit
Measured: Baseline (Week 0) to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start16 Jul 2010
- Primary completion31 May 2017
- Study completion31 May 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147965
- Sponsor's protocol ID
- QUILT-3.038
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2010
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23624851Balint 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.
PubMed 25956394
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Active Immunotherapy With Ad5 [E1-,E2b-]-CEA(6D) Vaccine in Patients With Advanced or Metastatic Malignancies Expressing CEA
- ClinicalTrials.gov ID
- NCT01147965
- Acronym / sponsor ID
- QUILT-3.038
- Conditions
- Colorectal Cancer, Lung Cancer, Breast Cancer, Prostate Cancer
- Keywords
- Colon Cancer, Lung Cancer, Breast Cancer, CEA, Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2010 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I/II study with the primary purpose to determine the safety of immunization with Ad5 [E1-, E2B-]-CEA(6D), in patients with advanced or metastatic CEA-expressing malignancies. The secondary objectives are to evaluate CEA-specific immune responses to the immunizations and to obtain preliminary data on clinical response rate. The study population consists of patients with a histologically confirmed diagnosis of metastatic malignancy that is CEA positive who were previously treated with standard therapy known to have a possible survival benefit or refused such therapy. The study will determine the safety of three dosage levels of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase I component), and the maximally tolerated dose of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase II component). The study drug is Ad5 [E1-, E2B-]-CEA(6D) given by subcutaneous (SQ) injection every 3 weeks for 3 immunizations. We will evaluate safety in each cohort at least 3 weeks after the last patient in the previous cohort has received their first injection. 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). We are currently enrolling up to 10 additional patients (Cohort 6) to evaluate safety, immunogenicity, and efficacy at the highest dose of vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Ad5 CEA VaccineCohort 1: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^9 particles |
| Cohort 2 | Experimental | Biological: Ad5 CEA VaccineCohort 2: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^10 particles |
| Cohort 3 | Experimental | Biological: Ad5 CEA VaccineCohort 3: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^11 particles |
| Cohort 4 | Experimental | Biological: Ad5 CEA VaccineCohort 4 (Phase II Cohort at MTD): Ad5 [E1-, E2b-]-CEA(6D) at a dose of 1 x 10^11 particles |
| Cohort 5 | Experimental | Biological: Ad5 CEA VaccineCohort 5: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 5 x 10^11 particles |
| Cohort 6 | Experimental | Biological: Ad5 CEA VaccineCohort 6: Ad5 [E1-, E2b-]-CEA(6D) at a dose of 5 x 10^11 particles |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
- Karnofsky performance score of 70% or higher
- Estimated life expectancy > 3 months
Key exclusion criteria (12 listed)
- Patients with concurrent cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. Except for the permitted concomitant therapies (bevacizumab, cetuximab, trastuzumab, erlotinib, gefitinib, or hormonal therapy which patients must have been on for at least 3 months at the time of enrollment if they intend to continue them with the vaccine), there must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy (including radiotherapy) and study treatment. Patients must have recovered to grade 1 acute toxicities from prior treatment.
- 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.
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 |
|---|---|---|
| Ad5 CEA VaccineAd5 [E1-, E2b-]-CEA(6D) Vector Vaccine | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Number of Participants With Dose Limiting Toxicities
Time frame: Every 3 weeks for 9 weeks and every 3 months for 1 year
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).
Number of Participants With Adverse Events
Time frame: from the time of first dose to the 30 days past last dose of study drug, up to 330 days
3 secondary outcomes
Clinical Response Rate
Time frame: from first dose up to a year follow up
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Time frame: Baseline (Week 0) up to Week 9
CEA Antibody (ng/mL) by Visit
Time frame: Baseline (Week 0) to Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23624851Morse 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.
- Results publication: PubMed 25956394Balint 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.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Ad5 CEA Vaccine in people with Colorectal Cancer and Lung Cancer, run by NantCell, Inc. at 2 sites 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 32 inclusion and 12 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (time frame: Every 3 weeks for 9 weeks and every 3 months for 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147965, which also lists 2 linked publications.
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 25 Nov 2025.