This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent/progressive glioblastoma.
This study is an open-label, single-arm Phase I/II clinical trial comprising two parts: Phase I and Phase II. Phase I is a dose-escalation phase, with the primary objective of assessing the safety and tolerability of VRT106 at escalating doses in subjects with recurrent/progressive glioblastoma and confirming the Recommended Phase II Dose (RP2D). Phase II is a dose-expansion phase, in which subjects will receive VRT106 at the RP2D dose level, aiming to further evaluate the efficacy and safety of VRT106 in subjects with recurrent/progressive glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
VRT106,intravenous
The First Affiliated Hospital of USTC
Hefei, Anhui, China
NOT_YET_RECRUITINGSanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGEvaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
To evaluate the safety and tolerability of VRT106 in patients with recurrent/progressive glioblastoma and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.
Time frame: About 2 years
Overall survival
Time from initial administration to death
Time frame: About 2 years
Objective response rate
Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR)
Time frame: About 2 years
Distribution and shedding of VRT106 virus
Concentration of VRT106 virus in blood
Time frame: About 2 years
Overall survival rate
Overall survival rates at 6, 9 and 12 months
Time frame: About 2 years
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The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGShenzhen Second People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGTangdu Hospital of Air Force Medical University of the PLA
Xi’an, Shanxi, China
NOT_YET_RECRUITING...and 1 more locations