Neoplasms

All Conditions

Infections

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Virus Diseases

Vaccinia

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Communicable Diseases

Poxviridae Infections

DNA Virus Infections

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Irinotecan

Molgramostim

Sargramostim

Cetuximab

Oxaliplatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cola

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

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

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.

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.

Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

JX-594

James Burke, MD

Derek Jonker, MD

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)

Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

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.

Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.

Transgene

Jennerex Biotherapeutics

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29

Single Agent_ Cohort 1

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29

Single Agent_Cohort 2

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: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Irinotecan: 180 mg/m2 IV every 2 weeks.

Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

Combination_Cohort 3

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: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

Combination_Cohort 4

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29

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 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

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 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Kyoung Soo Ha, Head of Clinical Development

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29

Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study

JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29

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.

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.

Spots Global Cancer Trial Database for Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

Trial Identification

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Study Description

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