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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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma	NCT01394939	Colorectal Carc... CRC	JX-594 Irinotecan	18 Years -	SillaJen, Inc.
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma	NCT01394939	Colorectal Carc... CRC	JX-594 Irinotecan	18 Years -	SillaJen, Inc.

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