Clinical trial · Interventional
GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers
An Open Label, Non-randomized Phase 1b Study to Investigate the Safety and Effect of the Oncolytic Virus GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery for Curative-Intent or Palliative Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of the investigational product GL-ONC1. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Organ Cancers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GL-ONC1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GL-ONC1
- description
- Cohort 3, 5, 7, 8, 9
- interventionNames
- Biological: GL-ONC1
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
- timeFrame
- 2.5 years
- description
- Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
Secondary outcomes (4)
- measure
- The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
- timeFrame
- 2.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven diagnosis of advanced (AJCC, 7th Edition: stage III or IV) or aggressive solid organ cancer. * Patients must provide written consent for a core needle biopsy sample of tumor tissue (primary or metastatic). * Have evidence of measurable disease (according to RECIST Version 1.1: http:// www.recist.com). * Have an ECOG Performance Score of 0 to 2. * Have a life expectancy of at least 3 months. * Have adequate organ and marrow function * Negative serum pregnancy test for females of childbearing potential. * Have negative test result for HIV and Hepatitis B or C testing. * Have baseline anti-vaccinia antibody titer \< 10. Exclusion Criteria: * Current or anticipated use of other investigational agents or marketed anticancer agent while on study (from the time of enrollment through the time of surgery). * Patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study. * Small pox vaccination for 4 weeks before study therapy and during study treatment. * Have received prior gene therapy or therapy with cytolytic virus of any type. * Have clinically significant cardiac disease * Oxygen saturation \<90% measured by pulse oximetry at rest. * Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during the course of study. * Have known allergy to ovalbumin or other egg products. * Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) * Have a history of allergy to iodinated contrast media. * Patients with known brain metastases * Pregnant or nursing
References
Publications (0)
Data not yet available