Phase 1b Dose Escalation Study of Intravenous JX-594 in Metastatic, Refractory Colorectal Carcinoma

NCT01380600 | Completed Phase 1 Results FDA Drug

• 1 other identifier: JX594-IV-CRC014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.

Conditions

Carcinoma, Colorectal

Keywords

Vaccinia; Vaccinia Virus; JX-594; Jennerex; Colorectal Carcinoma; Colorectal cancer; Colon Cancer; Rectal Cancer; Pexa-Vec

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

  A DLT is defined as any of the following treatment-related adverse events: Grade 4 toxicity, Grade 3 hematologic toxicity for \> 5 days, or Grade 3 non-hematologic toxicities persisting for \> 7 days except for flu-like symptoms that respond to standard therapies. The number of participants with DLTs was used to determine the Maximally-Tolerated Dose (MTD) and/or Maximum-Feasible Dose (MFD) of JX-594.

  Up to Day 57 (assessed through 14 days following the 4th and final biweekly JX-594 infusion, an average of 8 weeks).

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Adverse events were collected and assessed to evaluate safety and tolerability. A Treatment-Emergent Adverse Event (TEAE) is defined as an event with a start date on or after the date of the first dose of study treatment, or an event present at baseline that worsened in severity after the first dose.

  Up to Day 71 (assessed through 28 days following the 4th and final biweekly JX-594 infusion, an average of 10 weeks).

Secondary Outcomes (2)

• Number of Participants in Each Best Overall Tumor Response Category Based on RECIST

  Up to Day 57 (Week 8)

• Overall Survival (OS)

  From the first dose of Pexa-Vec until death from any cause, assessed up to 24 months

Study Arms (1)

single arm; Dose escalation

OTHER

Dose escalation 1e6 pfu/kg bw, 1e7 pfu/kg bw, 3e7 pfu/kg bw of Recombinant Vaccinia GM-CSF JX-594

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

Interventions

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

Intravenous Dose Range: 1x10\^6 pfu/kg, 1x10\^7 pfu/kg, 3x10\^7 pfu/kg Up to 4 intravenous infusions administered over 60 minutes every 2 weeks.

Also known as: JX-594

single arm; Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed, advanced/metastatic colorectal carcinoma
• Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (if tumor advanced either immediately or within 3 months of the end of treatment)
• Resistance to Erbitux: patients with Ras mutations, or for whom Erbitux has failed (if tumor advanced either immediately or within 3 months of the end of treatment, or there is no response to Erbitux therapy due to a lack of expression of EGFR (epidermal growth factor))
• Karnofsky Performance Score (KPS) ≥ 70
• Age ≥18 years
• Laboratory Safety: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3,Total bilirubin ≤ 1.5 X ULN, INR ≤ 1.5, AST, ALT ≤ 2.5x ULN (in case of liver metastasis: AST,ALT ≤5.0 x ULN)
• Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic, a fasting glucose must be done and patients must be \> 160 mg/dL.
• Patients who, if they are sexually active, are willing and able to refrain from sexual activity for 3 weeks following JX-594 administration. Patients who are willing and able to use a permitted contraceptive for 3 months after the final administration of JX-594.

You may not qualify if:

• Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
• Known myeloproliferative disorders requiring systemic therapy
• History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
• History of acquiring opportunistic infections.
• Tumor(s) invading a major vascular structure (e.g. carotid artery)
• Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur
• Clinically uncontrolled and/or rapidly accumulating ascites, pericardial and/or pleural effusions
• History of severe or unstable cardiac disease
• Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
• Administered anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
• Use of anti-viral, anti-platelet, or anti-coagulation medication \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\] Low dose aspirin (approximately 81 mg) allowed.
• Pulse oximetry O2 saturation \<90% Pulse oximetry O2 saturation \<90% at rest
• Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
• Pregnant or nursing
• Women who are pregnant or nursing an infant

Sponsors & Collaborators

• Jennerex Biotherapeutics: lead
• Samsung Medical Center: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Vaccinia; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Seunghyun Ma, M.D., Ph.D., Chief Medical Officer
• Organization: SillaJen Biotherapeutics, Inc.

medical_affairs@kr.sillajen.com

(415) 281-8886

Study Officials

• Young Suk Park, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: September 8, 2010
• Primary Completion: October 18, 2012
• Study Completion: October 18, 2012
• Last Updated: July 8, 2026
• Results First Posted: July 8, 2026

Record last verified: 2026-06

Locations

KR (1)