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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRT106 | Experimental | VRT106 will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRT106 | Drug | VRT106,intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate 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. | About 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from initial administration to death | About 2 years |
| Objective response rate | Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengcheng Guo | Contact | 020-87343990 | guochch@sysucc.org.cn | |
| Ke Sai | Contact | 020-87343890 | saike@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chengcheng Guo | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Not yet recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| About 2 years |
| Distribution and shedding of VRT106 virus | Concentration of VRT106 virus in blood | About 2 years |
| Overall survival rate | Overall survival rates at 6, 9 and 12 months | About 2 years |
| Sanbo Brain Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The Cancer Hospital Affiliated to Chongqing University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Nanfang Hospital, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
|
| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | China |
|
| Tangdu Hospital of Air Force Medical University of the PLA | Not yet recruiting | Xi’an | Shanxi | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |