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 个研究点目标入组 7 人开始时间: 2020年2月26日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Virogin Biotech Australia Pty. Ltd.