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
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Life expectancy ≥ 12 weeks. * Baseline organ function and laboratory data meet the following criteria:…
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.
Locations (5)
- Cedars Sinai Medical CenterLos Angeles, California
- Kansas University Cancer CenterFairway, Kansas
- Montefiore Medical CenterThe Bronx, New York
- Jilin Cancer HospitalChangchun, Jilin
- The first Bethune hospital of Jilin UniversityChangchun, Jilin