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| Name | Class |
|---|---|
| SystImmune Inc. | INDUSTRY |
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In this study, the safety, tolerability and preliminary effectiveness of GNC-039 in patients with relapsed/refractory or metastatic glioma or other solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-039.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | After the completion of the first cycle of treatment, if the patient has no intolerable toxic side effects during the first cycle of treatment, the investigator can communicate with the patient whether to continue the treatment during the 2-8 cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNC-039 | Drug | Administration by intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration. | Up to 14 days after the first dose of GNC-039 |
| Maximum tolerated dose (MTD) or maximum administrated dose (MAD) | In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD. | Up to 14 days after the first dose of GNC-039 |
| Treatment-Emergent Adverse Event (TEAE) | The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0). | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drug-related Adverse Events | Adverse Event (AE) refers to all adverse medical events that occur after a subject receives the investigational drug. Ae may be manifested as symptoms, signs, disease, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the investigational drug. | Up to approximately 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | +86-15013238943 | xiaosa@baili-pharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Li | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Cmax: Maximum serum concentration of GNC-039 | Maximum serum concentration (Cmax) of GNC-039 will be investigated. | Up to 14 days after the first dose of GNC-039 |
| Tmax: Time to maximum serum concentration (Tmax) of GNC-039 | Time to maximum serum concentration (Tmax) of GNC-039 will be investigated. | Up to 14 days after the first dose of GNC-039 |
| T1/2: Half-life of GNC-039 | Half-life (T1/2) of GNC-039 will be investigated. | Up to 14 days after the first dose of GNC-039 |
| AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity | Blood concentration - Area under time line. | Up to 14 days after the first dose of GNC-039 |
| AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration | Blood concentration - Area under time line. | Up to 14 days after the first dose of GNC-039 |
| CL: Clearance in the serum of GNC-039 per unit of time | To study the serum clearance rate of GNC-039 per unit time. | Up to 14 days after the first dose of GNC-039 |
| Incidence and titer of ADA (Anti-drug antibody) | Frequency and titer of anti-GNC-039 antibody (ADA) will be evaluated. | Up to approximately 24 months |
| ORR (Objective Response Rate ) | ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1. | Up to approximately 24 months |
| OS (Overall Survival) | Overall survival is the time from randomization to death from any cause. | Up to approximately 24 months |
| PFS (Progression-free Survival) | The PFS is defined as the time from the participant's first dose of GNC-039 to the first date of either disease progression or death, whichever occurs first. | Up to approximately 24 months |
| DOR (Duration of Response) | The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first. | Up to approximately 24 months |
| Affiliated Cancer Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
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| ZhuJiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
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| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Recruiting | Xian | Shanxi | China |
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| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |