Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT05525559
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors
Sponsor:
Etern BioPharma (Shanghai) Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_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:
FIRST
Brief Summary:
This is a Phase I, open-label, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0038 in patients with advanced solid tumors. It is anticipated that approximately 34 subjects will be enrolled in the dose-escalation phase of the study. ET0038 will be administered orally once daily (QD) in 21-day treatment cycles.
Detailed Description:
This is an open-label, multicenter, Phase 1 study of oral ET0038 monotherapy in participants with advanced solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with advanced solid tumors and 2) a Dose-Expansion Component for participants with advanced solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Study Oversight
Has Oversight DMC:
False
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?: