A Phase 1/2 interventional study of JX-594 and Irinotecan in Colorectal Carcinoma and CRC, sponsored by Jennerex Biotherapeutics. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Jennerex Biotherapeutics · Phase 1/2, Interventional, and Treatment
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.
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 52 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jennerex Biotherapeutics is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: JX-594
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
Biological: JX-594
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.
Biological: JX-594 · Drug: Irinotecan
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.
Biological: JX-594 · Drug: Irinotecan
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Also known as: Pexa-Vec
180 mg/m2 IV every 2 weeks.
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.
Time frame: Scans every 8 weeks until progression, assessed up to 25 months
Progression Free Survival
PFS (based on mRECIST) as determined by Independent Central Review is summarized for the ITT Population.
Time frame: 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
Time frame: Monthly until Death or Lost-to-Followup, assessed up to 25 months
Of the 66 patients screened, 52 patients were enrolled into the study. For the ITT Population, 3 patients were enrolled in Cohort 1, 24 patients were enrolled in Cohort 2, 5 patients were enrolled in Cohort 3, and 20 patients were enrolled in Cohort 4 (Pexa-Vec 1 x 109 pfu + irinotecan). Two patients (1 patient each in Cohorts 2 and 4) had pre-dosing AEs that led to discontinuation from the study prior to receiving treatment and were therefore excluded from the safety population and the PPP.
| Milestone | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Started | 3 | 24 | 5 | 20 |
| Intent-to-treat (itt) population | 3 | 24 | 5 | 20 |
| Safety population | 4 | 25 | 4 | 17 |
| Per protocol population (ppp) | 3 | 23 | 5 | 19 |
| Evaluable patient population (epp) | 3 | 21 | 4 | 17 |
| Radiographic evaluable patient population (repp) | 3 | 15 | 3 | 16 |
| Completed | 3 | 15 | 4 | 10 |
| Not completed | 0 | 9 | 1 | 10 |
| Withdrew: Adverse event | 0 | 3 | 1 | 4 |
| Withdrew: Death | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 |
| Withdrew: Others | 0 | 2 | 0 | 3 |
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.
| Participants | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| ORR at Week 8 (CR+PR) | 0 | 0 | 0 | 1 |
| ORR During the study (CR+PR) | 0 | 0 | 0 | 0 |
PFS (based on mRECIST) as determined by Independent Central Review is summarized for the ITT Population.
| Months | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Progression Free Survival | 1.7 (1.7 to 1.8) | 1.9 (1.5 to 2.0) | 2.2 (1.9 to 4.1) | 3.4 (1.8 to 5.0) |
Compare overall survival time of patients treated with JX-594 alone or in combination with irinotecan
| Months | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Overall Survival | 4.9 (3.1 to 15.1) | 3.4 (2.6 to 6.4) | 4.1 (2.2 to 10.3) | 6.4 (3.6 to 9.3) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Agent_ Cohort 1 | 3/3 (100%) | 2/4 (50%) | 4/4 (100%) |
| Single Agent_Cohort 2 | 24/24 (100%) | 10/25 (40%) | 25/25 (100%) |
| Combination_Cohort 3 | 5/5 (100%) | 1/4 (25%) | 4/4 (100%) |
| Combination_Cohort 4 | 19/20 (95%) | 8/17 (47.1%) | 17/17 (100%) |
| Event | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Blood bilirubin increasedInvestigations | 1/4 | 0/25 | 0/4 | 0/17 |
| Pelvic infectionInfections and infestations | 0/4 | 0/25 | 1/4 | 0/17 |
| Troponin increasedInvestigations | 1/4 | 0/25 | 0/4 | 0/17 |
| Disease progressionGeneral disorders | 0/4 | 2/25 | 0/4 | 0/17 |
| IleusGastrointestinal disorders | 0/4 | 2/25 | 0/4 | 0/17 |
| Aortic stenosisVascular disorders | 0/4 | 0/25 | 0/4 | 1/17 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 0/25 | 0/4 | 1/17 |
| Clostridium difficile colitisInfections and infestations | 0/4 | 0/25 | 0/4 | 1/17 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 0/25 | 0/4 | 1/17 |
| Duodenal perforationGastrointestinal disorders | 0/4 | 0/25 | 0/4 | 1/17 |
| Event | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 4/4 | 13/25 | 4/4 | 14/17 |
| VomitingGastrointestinal disorders | 1/4 | 12/25 | 4/4 | 10/17 |
| ChillsGeneral disorders | 4/4 | 19/25 | 4/4 | 15/17 |
| FatigueGeneral disorders | 2/4 | 7/25 | 4/4 | 12/17 |
| PyrexiaGeneral disorders | 4/4 | 23/25 | 4/4 | 17/17 |
| Decreased appetiteMetabolism and nutrition disorders | 2/4 | 4/25 | 4/4 | 7/17 |
| TachycardiaCardiac disorders | 2/4 | 6/25 | 3/4 | 7/17 |
| Abdominal painGastrointestinal disorders | 3/4 | 7/25 | 2/4 | 5/17 |
| Abdominal pain upperGastrointestinal disorders | 0/4 | 3/25 | 3/4 | 1/17 |
| Oedema peripheralGeneral disorders | 1/4 | 7/25 | 3/4 | 4/17 |
Baseline characteristics were analyzed based on the Safety Population (N=50).
| Age, Continuous(years) | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | Total |
|---|---|---|---|---|---|
| Mean | 64.3 ± 8.06 | 58.3 ± 11.84 | 58.8 ± 13.74 | 58.6 ± 10.42 | 58.9 ± 11.05 |
| Sex: Female, Male(Participants) | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | Total |
|---|---|---|---|---|---|
| Female | 0 | 13 | 1 | 6 | 20 |
| Male | 4 | 12 | 3 | 11 | 30 |
| Race (NIH/OMB)(Participants) | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 3 | 3 |
| White | 4 | 25 | 4 | 11 | 44 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 4 | 25 | 4 | 15 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
The record gives a start of Jan 2012, a primary completion of Jun 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2021, 5 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: JX-594
Jennerex Biotherapeutics