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.
Patients with histologically or cytologically confirmed advanced solid tumor that is positive for EGFR and has progressed despite standard therapy or for whom no standard therapy exists.
Patients are required to have archival tumor tissue available for assessment of EGFR status via FDA-approved EGFR assay .
Age ≥ 18 years.
Patients must have at least 1 measurable lesion as defined by RECIST v1.1.
History of another primary cancer ≤ 3 years, with the exception of completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix.
Active or symptomatic CNS metastases. Patients with treated CNS metastases that have been stable for ≥ 4 weeks and do not require treatment with steroids or anticonvulsants may be enrolled at the discretion of the Investigator.
Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency virus infection.
Active, clinically significant infections.
Sequential
ZZ06
Biological/VaccineThe 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.
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Treatment groupsSee each treatment group below.
ZZ06 AEs
Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
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
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
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.
PK parameters: Cmax
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
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.
PK parameters: t1/2
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
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Changchun Intellicrown Pharmaceutical Co. LTD
Lead sponsor
Covance
Collaborator
