This is a Phase I clinical study for evaluating the safety, pharmacokinetics, and preliminary efficacy of repeated doses, dose escalation of GR1405 injection in patients with advanced solid tumor or lymphoma
To evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy of GR1405 injection monotherapy in an open, non-controlled, escalating trial design in patients with advanced solid tumors or lymphomas. Four dose levels (3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg) were evaluated at this stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China
Maximum tolerated dose (MTD)
Maximum tolerated dose of GR1405 injection
Time frame: 2 weeks
Adverse Events
Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.03
Time frame: Approximately 3 years
maximum concentration (Cmax)
the maximum exposure to a biologically active physica
Time frame: Approximately 2 years
Duration of response (DOR)
DOR by RECIST v. 1.1 or Lugano 2014, the time between the initial response to therapy and subsequent disease progression or relapse
Time frame: Approximately 3 years
Objective Response Rate(ORR)
Objective Response Rate(ORR) by RECIST v. 1.1 or Lugano 2014, ORR=complete response(CR) + partial response(PR)
Time frame: Approximately 3 years
Progression free survival(PFS)
Progression free survival(PFS) by RECIST v. 1.1 or Lugano 2014, a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works
Time frame: Approximately 3 years
Immunogenicity
the ability to elicit an immune response of GR1405 injection,
Time frame: Approximately 3 years
Recommended dose for Phase II trial(RP2D)
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The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced dose-limiting toxicity(DLT) attributable to the study drug. The MTD will be the RP2D
Time frame: Approximately 3 years
AUC0-t
Area under the curve in the period from 0 to t
Time frame: Approximately 2 years
AUC0-∞
Area under the curve in the period from 0 to ∞
Time frame: Approximately 2 years
AUCss
Area under the curve of Steady-State Plasma Concentrations
Time frame: Approximately 2 years
T max
the time of occurrence of peak drug concentration
Time frame: Approximately 2 years
t 1/2
the time of half-life of the drug
Time frame: Approximately 2 years
apparent volume of distribution (Vz)
the volume of fluid that would be required to contain the amount of drug in the body
Time frame: Approximately 2 years
clearance(CL)
the rate of elimination of the drug in vivo
Time frame: Approximately 2 years