Colorectal CarcinomaPhase 1/2NCT01394939
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
A Phase 1/2 study testing JX-594 and Irinotecan in people with Colorectal Carcinoma and CRC, run by Jennerex Biotherapeutics at 11 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, CRC
- What is being tested?
- JX-594 and Irinotecan
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jan 2012to Oct 2015
- 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
- Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
- Failed treatment with irinotecan
- Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
- Regorafenib-naïve (have not received regorafenib)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
- Measurable tumor (≥1 cm longest diameter)
- Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)
Who cannot join
- Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
- Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
- Significant immunodeficiency due to underlying illness and/or medication
- History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
- Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
- Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
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- Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms
- Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
- Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
- Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
- Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
- Pregnant or nursing an infant
- Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States6 sites
Billings Clinic Cancer Center
Billings, Montana, 59101
Gabrail Cancer Center
Canton, Ohio, 44718
University of North Carolina
Chapel Hill, North Carolina, 27599-1651
The Ohio State University
Columbus, Ohio, 43210
UCSD Moores Cancer Center
La Jolla, California, 92093
Mayo Clinic
Scottsdale, Arizona, 85259-5499
France3 sites
Hôpital Saint Antoine
Paris, 75012
Hôpital Hautepierre
Strasbourg, 67200
Institut Claudius Regaud
Toulouse, 31052
Canada2 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Ottawa Hospital and Research Institute (OHRI)
Ottawa, Ontario, K1H 8L6
About this study
Official title: A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
Read the detailed description
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
- Conditions
- Colorectal Carcinoma, CRC
- Being tested
- JX-594, Irinotecan
- Keywords
- Vaccinia, Vaccinia Virus, JX-594, Jennerex, Colorectal Carcinoma, Colorectal cancer, Colon Cancer, Rectal Cancer, oncolytic virus, viral therapy, RAS mutant, Erbitux failure, Oxaliplatin failure, FOLFOX failure, FOLFIRI failure, Irinotecan failure, Pexa-Vec
- Medical subject headings
- Colorectal Neoplasms, Vaccinia, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX-594Biological
Also called Pexa-Vec
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
IrinotecanDrug
180 mg/m2 IV every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single Agent_ Cohort 1 | Experimental | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 Receives: Biological: JX-594 |
| Single Agent_Cohort 2 | Experimental | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 Receives: Biological: JX-594 |
| Combination_Cohort 3 | Experimental | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. Receives: Biological: JX-594; Drug: Irinotecan |
| Combination_Cohort 4 | Experimental | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. Receives: Biological: JX-594; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
Percentage of participants with overall response (CR+PR) during the study per mRECIST 1.1. CR: disappearance of enhancing area; PR: >=30% decrease in sum of enhancing area diameters.
Per mRECIST 1.1, an objective response at week 8 must be confirmed by a subsequent scan to be classified as an overall response during the study. If a participant achieved a response at week 8, but the response was not confirmed at the subsequent visit, then the participant may be included in the 'ORR at Week 8 (CR+PR)' Row, but may not be included in the 'ORR During the study (CR+PR)' Row.
Measured: Scans every 8 weeks until progression, assessed up to 25 months
Secondary outcomes (2)
Progression Free Survival
PFS (based on mRECIST) as determined by Independent Central Review is summarized for the ITT Population.
Measured: CT scans every 8 weeks until progression, assessed up to 25 months
Overall Survival
Compare overall survival time of patients treated with JX-594 alone or in combination with irinotecan
Measured: Monthly until Death or Lost-to-Followup, assessed up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionOct 2015
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 Colorectal CarcinomaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennerex Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Transgene
- Responsible party
- Sponsor
- Investigators
- James Burke, MD, Study director, Jennerex BiotherapeuticsDerek Jonker, MD, Principal investigator, Ottawa Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394939
- Sponsor's protocol ID
- JX594-CRC019
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2011
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
- ClinicalTrials.gov ID
- NCT01394939
- Acronym / sponsor ID
- JX594-CRC019
- Conditions
- Colorectal Carcinoma, CRC
- Keywords
- Vaccinia, Vaccinia Virus, JX-594, Jennerex, Colorectal Carcinoma, Colorectal cancer, Colon Cancer, Rectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jennerex BiotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Transgene
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Posted 8 Jan 2021
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 evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
Detailed description
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Agent_ Cohort 1 | Experimental | Biological: JX-594JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 |
| Single Agent_Cohort 2 | Experimental | Biological: JX-594JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 |
| Combination_Cohort 3 | Experimental | Biological: JX-594, Drug: IrinotecanJX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
| Combination_Cohort 4 | Experimental | Biological: JX-594, Drug: IrinotecanJX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
- Failed treatment with irinotecan
- Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
- Regorafenib-naïve (have not received regorafenib)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Key exclusion criteria (13 listed)
- Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
- Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
- Significant immunodeficiency due to underlying illness and/or medication
- History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
- Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
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 |
|---|---|---|
| JX-594Also: Pexa-VecRecombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) | Biological | Combination_Cohort 3, Combination_Cohort 4, Single Agent_ Cohort 1, Single Agent_Cohort 2 |
| Irinotecan180 mg/m2 IV every 2 weeks. | Drug | Combination_Cohort 3, Combination_Cohort 4 |
Primary outcome
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
Time frame: Scans every 8 weeks until progression, assessed up to 25 months
Percentage of participants with overall response (CR+PR) during the study per mRECIST 1.1. CR: disappearance of enhancing area; PR: >=30% decrease in sum of enhancing area diameters. Per mRECIST 1.1, an objective response at week 8 must be confirmed by a subsequent scan to be classified as an overall response during the study. If a participant achieved a response at week 8, but the response was not confirmed at the subsequent visit, then the participant may be included in the 'ORR at Week 8 (CR+PR)' Row, but may not be included in the 'ORR During the study (CR+PR)' Row.
2 secondary outcomes
Progression Free Survival
Time frame: CT scans every 8 weeks until progression, assessed up to 25 months
Overall Survival
Time frame: Monthly until Death or Lost-to-Followup, assessed up to 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Burke, MD study director
Jennerex Biotherapeutics
Derek Jonker, MD principal investigator
Ottawa Hospital and Research Institute
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JX-594 and Irinotecan in people with Colorectal Carcinoma and CRC, run by Jennerex Biotherapeutics at 11 sites in 3 countries.
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 7 inclusion and 13 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Canada. 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 8 Jan 2021). 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?
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study (time frame: Scans every 8 weeks until progression, assessed up to 25 months). 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 5 Aug 2026.