ACTRN12620000244909
Terminated
Phase 1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG161 in Subjects with Advanced Malignant Solid Tumors that are Refractory to Conventional Therapies
Virogin Biotech Australia Pty. Ltd.0 sites7 target enrollmentFebruary 26, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced malignant solid tumors
- Sponsor
- Virogin Biotech Australia Pty. Ltd.
- Enrollment
- 7
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject will be ligible for study participation if all the following criteria are met:
- •1\. Signed written informed consent.
- •2\. Males or females aged greater than or equal to 18 years.
- •3\. Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1\.
- •4\. Subject with advance malignant Solid tumors which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
Exclusion Criteria
- •A subject will be ineligible for study participation if any of the following criteria are met:
- •1\. Participation in any trial of any other investigational agent within the last 4 weeks prior to trial screening dosing. Wash out periods to be reviewed on a case by case basis with Medical Monitor, as required
- •2\. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
- •3\. Subjects with any primary CNS malignancy including glioma and current, active, progressing CNS malignancy, including carcinomatosis meningitis are excluded. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS\-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period and o steroids (for at least 2 weeks prior to rst dose of IP).
- •4\. Major surgery within 14 days prior to visit enrolment.
- •5\. Intercurrent serious infections within the 28 days prior to Screening visit commencement.
- •6\. Life\-threatening illness unrelated to cancer.
- •7\. Active Herpes infection.
- •8\. Treatment with antiviral agents within 14 days prior to Screening visit commencement
- •9\. Uncontrolled congestive cardiac failure.
Outcomes
Primary Outcomes
Not specified
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