This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.
The study will start with an accelerated-titration dose escalation scheme, enrolling 1 patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly, probably, or definitely related to the study drug. After the first 2 cohorts, the study will then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.
Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGKansas University Cancer Center
Fairway, Kansas, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGJilin Cancer Hospital
Changchun, Jilin, China
NOT_YET_RECRUITINGThe first Bethune hospital of Jilin University
Changchun, Jilin, China
RECRUITINGZZ06 AEs
Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: up to 36 weeks
Incidence of abnormal laboratory test results
The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart
Time frame: up to 36 weeks
Incidence of abnormal physical exam findings
The data of the physical examinations is collected and analyzed according to the time point of the test flow chart
Time frame: up to 36 weeks
PK parameters: Area under curve (AUC)
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Time frame: up to 28 weeks
PK parameters: Cmax
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Time frame: up to 28 weeks
PK parameters: Clearance rate (CL)
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Time frame: up to 28 weeks
PK parameters: t1/2
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Time frame: up to 28 weeks
PK parameters: Vz
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Time frame: up to 28 weeks
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