Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04412616
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-05-14
Brief Title:
ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies
Sponsor:
Changchun Intellicrown Pharmaceutical Co LTD
Organization:
Changchun Intellicrown Pharmaceutical Co LTD
Study Overview
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 EGFR Positive Solid Tumor Malignancies
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 33 design with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None