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.
After failure of standard treatment (surgery, stupp regimen), subjects with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other recurrent/refractory or metastatic solid tumors can understand the informed consent, voluntarily participate in and sign the informed consent.
No gender limitation.
Age: ≥18 years old.
KPS≥60 points.
Patients who are allergic to immunoglobulin or any component of the injectable formulation of GNC-039.
Patients with active infections requiring intravenous antibiotics who did not complete treatment 1 week prior to enrollment, except those who received prophylactic antibiotics for puncture or biopsy.
Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA copy number ≥ULN) or hepatitis C virus infection (HCV-RNA≥ULN).
Toxicity from prior antitumor therapy did not decrease to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities that the investigators judged to be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).
Single group
GNC-039
DrugAdministration by intravenous infusion.
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.
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.
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).
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.
Cmax: Maximum serum concentration of GNC-039
Maximum serum concentration (Cmax) of GNC-039 will be investigated.
Tmax: Time to maximum serum concentration (Tmax) of GNC-039
Time to maximum serum concentration (Tmax) of GNC-039 will be investigated.
T1/2: Half-life of GNC-039
Half-life (T1/2) of GNC-039 will be investigated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
SystImmune Inc.
Collaborator
