Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT04683250
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2020-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities
Sponsor:
Taiho Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities
Status:
RECRUITING
Status Verified Date:
2025-02
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:
MARGARET
Brief Summary:
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: