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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Administration by intravenous infusion.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Cancer Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
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.
Time frame: 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.
Time frame: 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).
Time frame: Up to approximately 24 months
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.
Time frame: Up to approximately 24 months
Cmax: Maximum serum concentration of GNC-039
Maximum serum concentration (Cmax) of GNC-039 will be investigated.
Time frame: 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.
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi, China
RECRUITINGWest China Hospital,Sichuan University
Chengdu, Sichuan, China
RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 24 months
OS (Overall Survival)
Overall survival is the time from randomization to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 24 months