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.
7
Treatment groupsSee each treatment group below.
Changchun Intellicrown Pharmaceutical Co. LTD
Lead sponsor
Covance
Collaborator