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ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD
Summary
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.
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-09-01
Completion Date
2026-07-06
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
ZZ06
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.
Locations (5)
Cedars Sinai Medical Center
Los Angeles, California, United States
Kansas University Cancer Center
Fairway, Kansas, United States
Montefiore Medical Center
The Bronx, New York, United States
Jilin Cancer Hospital
Changchun, Jilin, China
The first Bethune hospital of Jilin University
Changchun, Jilin, China