Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2025-12-17 @ 11:21 PM
Study NCT ID:
NCT05737706
Status:
None
Last Update Posted:
2025-04-06 00:00:00
First Post:
2023-02-10 00:00:00
Brief Title:
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc.
Study Overview
Official Title:
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Formulation challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.
This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
Detailed Description:
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen As potentially viable regimens are identified Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information and early evidence of clinical activity are available to recommend Phase 2 regimens In Phase 2 separate cohorts of patients by histological diagnosis andor baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA246-0005 | OTHER | None | None |
| 1133-001 | OTHER | None | None |