This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
The trial is planned to explore three main topics: 1.the dose of GPA33-CC. 2. the intervation between administration of GPA33-CC Inervation and 177Lu-SmartD2. 3.the mass dose of SmartD2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of AE/SAE after administration
Time frame: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Laboratory tests after administration
Time frame: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Vital signs after administration
Time frame: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Physical examination after administration
Time frame: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal ECG after administration
Time frame: 3 weeks
To evaluate the pharmacokinetic of the GPA33-CC protein
Peak plasma concentration (Cmax) of the GPA33-CC
Time frame: up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
half-life (t1/2) of the GPA33-CC
Time frame: up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
Area under the concentration-time curve (AUC) of the GPA33-CC
Time frame: up to 1 week
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To evaluate the radiological characteristics 177Lu-SmartD2.
Rradiation doses in whole blood and serum measured using a gamma counter radiological characteristics 177Lu-SmartD2 will be performed.
Time frame: up to 1 week
To evaluate the biodistribution of SNA028
Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
Major organ and tumour standardised uptake (SUVmax and SUVmean)
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
The retention time of major organs and tumor.
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
The tumour-to-background ratio (TBR) of SUV
Time frame: up to 2 weeks
Assessment of the immunogenicity of GPA33-CC
Occurance of positive immunogenicity
Time frame: 4 weeks