To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT
phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administration by intravenous infusion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGHarbin First Hospital
Haerbin, Heilongjing, China
RECRUITINGQingdao Central Hospital
Qingdao, Shandong, China
RECRUITINGDose limiting toxicity (DLT)
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 14 days after the first dose
Maximum tolerated dose (MTD) or Maximum 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
Adverse Events during Treatment (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.
Time frame: Up to approximately 24 months
Recommended dose for Phase II clinical studies (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.
Time frame: Up to 14 days after the first dose
disease control rate (DCR)
Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.
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Time frame: Up to approximately 24 months
progression-free survival (PFS)
The PFS is defined as the time from the participant's first dose of GNC-038 to the first date of either disease progression or death, whichever occurs first.
Time frame: Up to approximately 24 months
Adverse Events of Special Interest (AESI)
AESI is an event of scientific and medical interest specific to the sponsor's product or research project.
Time frame: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of GNC-038 will be investigated.
Time frame: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of GNC-038 will be investigated.
Time frame: Up to approximately 24 months
AUC0-INF
Blood concentration - Area under time line.
Time frame: Up to approximately 24 months
AUC0-T
Blood concentration - Area under time line.
Time frame: Up to approximately 24 months
T1/2
Blood concentration - Area under time line.
Time frame: Up to approximately 24 months
anti-drug antibody (ADA) in Ⅰa
Frequency and titer of anti-GNC-038 antibody (ADA).
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