Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05245500
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-02-01
Brief Title:
Phase 12 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Status:
RECRUITING
Status Verified Date:
2024-08
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 a Phase 12 open-label multicenter study of the safety tolerability PK PD and anti-tumor activity of MRTX1719 patients with advanced unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene
Detailed Description:
This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen As potentially viable regimens are identified Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience PK information compare food effect and relative bioavailability between capsules and tablets 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 MRTX1719
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 |
|---|---|---|---|
| CA240-0007 | OTHER | None | None |
| 1719-001 | OTHER | None | None |