Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840510
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-04-12
Brief Title:
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation KRYSTAL -19
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Trial of Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 study will evaluate the safety MTD andor RP2D PK and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumorsNSCLC with a KRAS G12C mutation
Detailed Description:
This study will evaluate the safety and tolerability and clinical activity of adagrasib in combination with nab-sirolimus in patients with advanced solid tumors harboring a KRAS G12C mutation
The Phase 1 portion will enroll advanced solid tumors to establish the maximum tolerated dose MTD andor to identify recommended Phase 2 combinatorial doses The Phase 2 portion will enroll patients with NSCLC to further evaluate the safetytolerability and clinical activity
Adagrasib is an orally available small molecule inhibitor of KRAS G12C nab-Sirolimus is a nanoparticle albumin-bound nab form of sirolimus and sirolimus is an inhibitor of mechanistic target of rapamycin kinase mTOR previously known as mammalian target of rapamycin
The Phase 1 portion will enroll advanced solid tumors to establish the maximum tolerated dose MTD andor to identify recommended Phase 2 combinatorial doses The Phase 2 portion will enroll patients with NSCLC to further evaluate the safetytolerability and clinical activity
Adagrasib is an orally available small molecule inhibitor of KRAS G12C nab-Sirolimus is a nanoparticle albumin-bound nab form of sirolimus and sirolimus is an inhibitor of mechanistic target of rapamycin kinase mTOR previously known as mammalian target of rapamycin
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 |
|---|---|---|---|
| CA239-0011 | OTHER | None | None |
| 849-019 | OTHER | None | None |