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
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.
Detailed description
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.
Arms & interventions
- BiologicalZZ06
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.
Outcome measures
Primary
ZZ06 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
Secondary
PK parameters: Area under curve (AUC)
Time frame: up to 28 weeks
PK parameters: Cmax
Time frame: up to 28 weeks
PK parameters: Clearance rate (CL)
Time frame: up to 28 weeks
PK parameters: t1/2
Time frame: up to 28 weeks
PK parameters: Vz
Time frame: up to 28 weeks
Eligibility criteria
Study locations (3)
Cedars Sinai Medical Center
Los Angeles, California, 90048-1804
Kansas University Cancer Center
Fairway, Kansas, 66205-2528
Montefiore Medical Center
The Bronx, New York, 90048-1804