Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-29 @ 10:07 AM
Study NCT ID:
NCT04801095
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2021-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
Sponsor:
Wellmarker Bio
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Multicenter, Dose-escalation and Dose-expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of WM-S1-030 in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2022-09
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 study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.
Detailed Description:
This is a Phase I, open-label, multicenter, dose-escalation, and dose-expansion study of WM-S1-030 in patients with advanced or metastatic solid tumors. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will investigate oral administration of WM-S1-030 as monotherapy. Once the MTD or recommended dose is identified in Part 1, additional patients will be enrolled into Part 2 to further investigate efficacy, safety, PK, pharmacodynamics, dosing interval or schedule, and food effect on the single-dose PK of WM-S1-030.
Study Oversight
Has Oversight DMC:
False
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?: