Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 3:01 AM
Study NCT ID:
NCT07231068
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation
Sponsor:
Henan Genuine Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study on the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutations
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
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 an open label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.
Detailed Description:
Dositinib is an EGFR-TKI. There are two parts in the study. Phase I is dose escalation study, and Phase II is dose expansion study. Phase I will be conducted using 3+3 dose escalation method. In Phase II, 3 dose levels will be chosen to further evaluate the safety and efficacy of Dositinib.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: